EPA-340/1-80-016
Enforceability Aspects for
RACT for the Chemical Synthesis
Pharmaceutical Industry
by
T. Briggs, C. Harvey, J. McClure,
and R. Pollard-Cavalli
PEDCo Environmental, Inc.
11499 Chester Road
Cincinnati, Ohio 45246
Contract No. 68-01-4147
Task No. 128
EPA Project Officer: John R. Busik
Task Manager: Robert L King
Prepared for
U.S. ENVIRONMENTAL PROTECTION AGENCY
Office of General Enforcement
Division of Stationary Source Enforcement
Washington DC 20460
January 1981
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DISCLAIMER
This report was furnished to the U.S. Environmental Protection Agency by
PEDCo Environmental, Inc., in fulfillment of Contract No. 68014147. The
contents of this report are reproduced herein as received from the contractor.
The opinions, findings, and conclusions expressed are those of the author and
not necessarily those of the U.S. Environmental Protection Agency.
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CONTENTS
1 Introduction
Background of RACT
Purpose and Scope of Report
2 Industry Characterization
Overview of Pharmaceutical Industry
Process Description of Synthetic Pharmaceutical Industry
Geographical Distribution of Synthetic Pharmaceutical Industry
3 Control Techniques and Factors Affecting Enforcement
Summary of RACT Regulations
Control Technologies
Factors Affecting Enforcement
4 Recommendations For Further Investigation
Determining VOC Emissions
Clarifying the Bubble Concept
Extending Compliance Schedules
Appendix A
Appendix B
Page
1
1
1
2
2
9
13
13
14
16
19
19
19
19
A-l
B-l
m
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TABLES
Number
1
2
Distribution of Synthetic Pharmaceutical Manufacturing
Plants by EPA Regions
Distribution of Synthetic Pharmaceutical Manufacturing
Plants by States
Page
10
11
IV
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ACKNOWLEDGMENT
This report was prepared under the direction of Mr. Thomas C. Ponder, Jr.
The project manager and principal investigator was Dr. Terry M. Briggs.
Principal authors were Dr. Terry Briggs, Ms. Cynthia Harvey, Mr. Jack McClure,
and Ms. Roberta Pollard-Cavalli. Task Manager for the U.S. Environmental
Protection Agency was Mr. Robert L. King.
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SECTION 1
INTRODUCTION
BACKGROUND OF RACT
The Clean Air Act Amendments of 1977 (CAAA) required each state to report
compliance status with National Ambient Air Quality Standards (NAAQS) to the
U.S. Environmental Protection Agency (EPA). Attainment and nonattainment
areas of major pollutants in each state were listed in the Federal Register on
March 3, 1978. According to CAAA, nonattainment areas must achieve compliance
with NAAQS by December 31, 1982, with some possible extensions to 1987. Those
industries in areas where standards for a particular pollutant are not being
met will be required to apply Reasonably Available Control Technology (RACT)
under the State Implementation Plans (SIP). The RACT requirements are based
on the lowest emission limit that a particular source is capable of meeting by
the application of control technology that is reasonably available in terms of
technological and economic feasibility.
The RACT requirements for control of hydrocarbon emissions are explained
in the Control Technique Guidelines (CTG) series. It is necessary to limit
hydrocarbon emissions in order to reduce photochemical oxidant levels. With
respect to the pharmaceutical industry, RACT is applicable to those manufac-
turing plants using synthesis processes that emit more than 15 pounds per day
of volatile organic compounds (VOC).
PURPOSE AND SCOPE OF REPORT
A current survey of operating plants that manufacture synthetic pharma-
ceutical s in oxidant nonattainment areas is necessary for the enforcement of
RACT and for long-range planning of the programs and resources of EPA's Divi-
sion of Stationary Source Enforcement (DSSE), regional, and local programs.
There has been little previous regulation of air pollution control activ-
ity in this industry. The first phase of this study was to compile an inven-
tory of the pharmaceutical manufacturing plants that use synthesis processes.
The inventory includes plant demographic data, a categorization of the indus-
try by major synthetic pharmaceutical product groups, and emission and control
information.
As background for results of this survey, Section 2 presents an industry
process description and a review of the RACT requirements. An evaluation of
proposed regulations to identify enforceability problems is presented in
Section 3; conclusions and recommendations are given in Section 4.
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SECTION 2
INDUSTRY CHARACTERIZATION
OVERVIEW OF PHARMACEUTICAL INDUSTRY
The pharmaceutical manufacturing industry encompasses the manufacture
purification,^ packaging of chemical materials to be used as medication for
humans or animals. The broad range of industry products includes natural
substances from plants or animals, chemically modified natural substances,
synthetically made organic chemicals, metal-organics, and wholly inorganic
materials. Production activities of the pharmaceutical industry can be
grouped into the following categories:
Chemical synthesis - The manufacture of pharmaceutical products by
chemical synthesis.
Fermentation - The production and separation of medicinal chemicals such
as antibiotics and vitamins from microorganisms.
Extraction - The manufacture of botanical and biological products by the
extraction of organic chemicals from vegetative materials or animal
tissues.
Formulation and packaging - The formulation of bulk Pharmaceuticals into
various dosage forms such as tablets, capsules, injectable solu-
tions, ointments, etc., that can be taken by the patient immediate-
ly and in accurate amount.
Pharmaceutical manufacturers use many VOC either as raw materials or as
solvents. The Pharmaceutical Manufacturers Association (PMA) obtained from 26
member companies their estimates of the 10 VOC's that were purchased in larg-
est volumes. According to the data obtained, about 73 percent of all emis-
sions reported are from the chemical synthesis group. Therefore EPA is
considering only the chemical synthesis group for regulation of VOC emissions
PROCESS DESCRIPTION OF SYNTHETIC PHARMACEUTICAL INDUSTRY
Most^drugs are prepared today by chemical synthesis. The Effluent Guide-
lines Division of the EPA has compiled a comprehensive data base, which indi-
• SSon °f Pharmaceutica"l Plants manufacturing products by chemical synthe-
sis, 80 percent of all operations are batch processes, 8 percent are continu-
ous, and 12 percent are semicontinuous.
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The basic
welded bottom
driven agitator and an internal
steel or glass-lined carbon steel,
either cooling water or steam. Vessels
ent sizes, with capacities
accessories, these vessels
reaction vessel for the batch process is a mixing tank with a
and a clamped-on top. It is usually equipped with a motor-
baffle. The tank, made of either stainless
has a carbon steel outer shell suitable for
of this type are made in many differ-
With suitable
including the
ranging from 0.02 to 11 m3 or more.
can be used in many different ways
mixing, boiling, and chilling of solutions. With addition of a condenser, a
complete reflux operation is possible; vacuum operation is also possible. The
tanks can also be used for solvent extraction and crystallizing operations.
The manufacture of synthetic Pharmaceuticals consists of using one or
several of these vessels to perform the various needed operations, usually in
the following sequence: (a) reaction (sometimes multiple reactions);
(b) product separation; (c) purification; and (d) drying. Following a speci-
fic recipe, the reactor operator or computer-controlled mechanism blends
reagents; adjusts the flow rate of cooling water, chilled water, or steam; and
pumps the reactor contents into other similar vessels. At appropriate process
steps, solutions are pumped through filters or centrifuges into solvent recov-
ery headers or into waste sewers.
The vessels and their auxiliary equipment are usually combined into
independent process units; a large pharmaceutical plant may contain many such
units. Each unit may be suitable for the manufacture of many different phar-
maceutical intermediary and final compounds. Dedicated equipment is used only
for extremely high-volume production.
A pharmaceutical product is usually manufactured in a campaign, in which
one or more process units are used for a few weeks or months to manufacture
enough of this compound to satisfy its projected sales demand. Campaigns are
usually tightly scheduled, with detailed coordination extending from procure-
ment of raw materials to packaging and labelling of the product. For variable
periods of time, therefore, a process unit actively manufactures a specific
compound. At the end of each campaign, the same equipment and personnel are
used to make a completely different product, utilizing different raw materi-
als, executing a different formula, and creating different wastes.
Figure 1 shows a typical flow diagram for a batch synthesis operation.
At the start of a production cycle, the reactor is usually washed and steri-
lized. In this example, solid reactants and solvent are charged to a batch
reactor equipped with a condenser (which is usually water-cooled), and VOC may
be produced as products or byproducts. Any remaining unreacted solvent is
removed by distillation. When the reaction and solvent removal are complete,
the product is transferred to a holding tank, in which it undergoes three to
four washes of water or solvent to remove any remaining reactants and bypro-
ducts. The solvent used to wash may also be evaporated from the reaction
product. The crude product may then be dissolved in another solvent and
transferred to a crystallizer for purification. After crystallization, the
solid material is centrifuged from the remaining solvent. In the centrifuge,
the product cake may be washed several times with water or solvent. Tray,
rotary, or fluid-bed dryers may then be used for final product finishing.
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Organic chemicals are used as raw materials and solvents; solvents are
responsible for the predominant VOC emissions from production. Almost every
pharmaceutical process reaction step requires a solvent chemical to dissolve
reactants and to bring them into close proximity with each other. A solvent
also aids in process heat transfer and temperature control.
The synthetic pharmaceutical 'industry uses a wide variety of reaction and
purification solvents, including water. Benzene and toluene, stable compounds
that do not easily react, are the most often used organic solvents. .Similar
compounds such as xylene, cyclohexane, and pyridine are also used. Chlori-
nated hydrocarbons are used occasionally in purification operations, but are
rarely used as reaction solvents.
Each operation of the chemical synthesis process may be a source of VOC
emissions which vary widely within and among operations, depending on the
amount and type of VOC used, the manufacturing equipment, and the size of the
operation. Because of the wide variation, typical emission rates for each
operation cannot be calculated. The CTG, however, establishes an approximate
ranking of emission sources, as shown below. The first four sources generally
account for most of the emissions from a plant.
Dryers
Reactors
Distillation units
Storage and transfer
Filters
Extractors
Centrifuges
Crystal!izers
Applicable controls for these emission sources include condensers, scrub-
bers, and carbon adsorbers. Use of incinerators is expected to be limited to
a few specific applications. Storage and transfer emissions can be controlled
by vapor return lines, vent condensers, conservation vents, vent scrubbers
pressure tanks, and carbon adsorbers. Floating roofs may be feasible controls
for large storage tanks.
Dryers
Dryers remove most of the remaining solvent from a centrifuged or fil-
tered product. Solvent is evaporated until an acceptable level of dryness is
reached Evaporation is accelerated by applying heat and/or vacuum to the
solvent-laden product or by blowing warm air around or through it. Because
many products degrade under severe drying conditions, the amount of heat
vacuum, or warm air flow must be carefully controlled. Several types of
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dryers are used in synthetic drug manufacture, including tray, rotary, and
fluid bed dryers.
A typical tray dryer consists of a rectangular chamber containing two
carts with support racks. Each rack carries a number of shallow trays that
are loaded with the product to be dried. Heated air is circulated within the
chamber.
A rotary or tumbler dryer consists of a revolving cylindrical or conical
shell supported in a horizontal or slightly inclined position. Rotary dryers
may be operated under vacuum or with hot air circulation. Rotation of the
dryer tumbles the product to enhance solvent evaporation and may also perform
a blending function.
A fluid bed dryer evaporates solvent by forcing heated air through the
wet material. Typically, a large pan loaded with the product is placed inside
the dryer, where air is blown through the bottom of the pan. The air agitates
or fluidizes the product. Some product particles may be entrained in the gas
stream. They are captured by a fabric filter and returned to the dryer.
A dryer is a potentially large emission source. Emission rates are
highest at the beginning of the cycle and lowest at the end of the cycle.
Dryer size, number of drying cycles per year, and the amount and type of
solvent evaporated per cycle affect the total emissions. Emissions from an
air dryer are normally greater than those from a vacuum dryer, mainly because
emissions from the air dryer are dilute and more difficult to control.
Reactors
A typical batch reactor is made of stainless steel or glass-lined carbon
steel. The tank is usually jacketed to permit temperature control of reac-
tions. Generally, each is equipped with a vent, which may discharge through a
condenser. Batch reactors may also be used as mixers, heaters, holding tanks,
crystal!izers, and evaporators.
Reactor emissions may stem from the following: (a) displacement of air
containing VOC during reactor charging; (b) evaporation of solvent during the
reaction cycle (reaction byproduct gases act as VOC carriers in many opera-
tions); (c) venting of uncondensed VOC from an overhead condenser during
refluxing; (d) purging of vaporized VOC remaining from a solvent wash; and
(e) opening of a reactor during a reaction cycle to take samples or determine
reaction endpoints.
Emissions may be greater when a reactor is operated under pressure
because the pressure must be relieved between cycles. This may be done by
venting directly to the atmosphere or through a condenser. When the reactor
is vented through an overhead condenser, care must be taken not to overload
the condenser by relieving reactor pressure too rapidly. The number of
batches or annual throughput will affect total emissions from the reactor.
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Distillation Units
Distillation is performed by either of two principal methods. The first
method is based on production of a vapor by boiling the liquid mixture and
condensing the vapors without allowing any liquid to return to the still The
second method is based on the return of part of the condensate to the still so
that the returning liquid is brought into intimate contact with the vapors on
the way to the condenser. Either of these methods may be conducted as a batch
or continuous operation.
Distillation may be performed in batch reactors, in small stills attend-
ant to reactors, or in larger distillation columns such as may be used for
waste solvent recovery. The largest distillation columns in pharmaceutical
plants process around 3200 kg/h (7000 Ib/h) of feed material. The distilla-
tion condensers used to recover evaporated solvents may emit VOC.
Storage and Transfer
Volatile organic compounds are stored in tank farms, in 55-gallon drums
and sometimes in process holding tanks. Capacities of storage tanks in tank
farms range from about 20,000 to 110,000 liters (5,000 to 30,000 qallons)
Most are horizontal tanks, although vertical tanks also are used. Process
cA™9 tanks are Sma11er> with capacities from 2,000 to 20,000 liters (500 to
5,000 gallons). In-plant transfer of VOC is done mainly by pipeline, but also
may be done manually. Raw materials are delivered to the plant by tank truck
rail car, or in 55-gallon drums.
Emissions of VOC from storage tanks are from working losses or breathing
losses The amount of loss depends on the type of VOC stored, size of tank
type of tank, diurnal temperature changes, and tank throughput.
Filters
Generally, filtration is used to remove solids from a liquid, whether
these solids are product, process intermediates, catalysts, or carbon parti-
cles (eg from a decoloring step). The normal filtration procedure is
simply to force or draw the mother liquor through a filtering medium. After
nitration, the retained solids are removed from the filter medium for further
processing. Pressure filters, such as shell and leaf filters, cartridge fil-
ters, and plate and frame filters, are commonly used. Atmospheric and vacuum
filters are used in some applications.
Enclosed pressure filters normally do not emit VOC during a filtering
operation. The filtered liquid is sent to a receiving tank. Emissions can
occur when a filter is opened to remove collected solids. Emissions can also
occur if the filter is purged before cleaning. The purge gas entrains evapo-
rated solvent and probably is vented through the receiving tank.
Highest VOC emissions are from vacuum drum filters, in which solvent is
pulled through a precoated filter drum. Potential emissions are significant
both at or near the surface of the drum and from the ensuing waste stream
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Extraction
Extraction is used to separate components of liquid mixtures or solu-
tions. This process is based on differences in solubilities of the compon-
ents; i.e., a solvent is used that will preferentially combine with one of the
components. The resulting mixture is made up of the extract, which contains
the preferentially dissolved material, and the raffinate, which is the resid-
ual phase.
The pharmaceutical industry generally utilizes two kinds of solvent
extraction. In the first, the extraction takes place within the reactor.
Solvent is added to the vessel, and the mixture is agitated until the material
to be extracted is dissolved. The mixture is then allowed to separate into
two phases, and the bottom layer is drawn off and transferred to a second
vessel.
The second type of extraction takes place in a vertical column. A sol-
vent is made to flow through the liquid mixture. Either-the solvent or the
mixture is dispersed before entering the column; this increases contact and
promotes the extraction process. Further extraction efficiency may be gained
by using a packed column.
Emissions from batch extraction stem mainly from displacement of vapor
while solvent is pumped into the extractor and while the vessel is purged or
cleaned after extraction. Some VOC also may be emitted while the liquids are
being agitated. Column extractors may emit VOC during filling or emptying of
the column or during extraction. Emissions also occur through associated
surge tanks. Significant amounts of solvent may be emitted from these tanks
because of working losses as the tank is repeatedly filled and emptied during
the extraction process.
Centrifuges
Centrifuges are used to remove intermediate or product solids from a
liquid stream. Center-slung, stainless steel, basket centrifuges are most
commonly used. When the centrifuge is started, liquid slurry is pumped into
it. An inert gas, such as nitrogen, is sometimes introduced into the centri-
fuge to avoid the buildup of an explosive atmosphere. The liquid is strained
through small basket perforations, and solids are retained in the basket. The
solids are then scraped from the sides of the basket; they are unloaded by
being scopped through a hatch on top of the centrifuge or dropped through the
bottom into receiving carts.
A large potential source of VOC emissions is the open-type centrifuge,
which permits large quantities of air to contact and evaporate solvents. The
trend is toward complete enclosure of the centrifuge. If an inert gas blanket
is used, it will be a transport vehicle for solvent vapor. This vapor may be
vented directly from the centrifuge or from a process tank receiving mother
liquor.
The solids are still wet with solvent and are a source of emissions while
being unloaded and transported to the next process step. A bottom unloader
can minimize this problem if the solids are transferred to a receiving cart
8
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through
solids.
a closed chute and the receiving cart is covered while transporting
Crystal!izers
Crystallization is a means of separating an intermediate or final product
from a liquid solution. This is done by creating a supersaturated solution,
one in which the desired compounds will form crystals. Supersaturation may be
achieved in three ways: (1) if solubility of the solute increases strongly
with temperature, a saturated solution becomes supersaturated by simple
cooling; (2) if solubility is relatively independent of temperature, super-
saturation may be attained by evaporating a portion of the solvent; (3) if
neither cooling nor evaporation is desirable, supersaturation may be induced
by adding a third component to form a mixture in which the solute is consider-
ably less soluble.
Crystallization by cooling a solution will generate little VOC"emission.
Crystallization by solvent evaporation increases the potential for emissions.
Emissions are significant if evaporated solvent is vented directly to the
atmosphere. More frequently, the solvent is passed through a condenser or a
vacuum jet.
GEOGRAPHICAL DISTRIBUTION OF SYNTHETIC PHARMACEUTICAL PLANTS
It is estimated that 800 to 1200 plants in the United States manufacture
pharmaceutical products, of which 140 use synthesis processes. The 140 plants
are scattered through 30 states and Puerto Rico and are located in all ten EPA
regions.
Geographical Distribution
More than 41 percent of the plants in the synthetic chemical industry are
located in EPA Region II. New Jersey and New York have 27 and 23 plants,
respectively, and each plant is in a nonattainment area for oxidants. Only
the 8 plants in Puerto Rico are in attainment areas.
EPA Region V has 27 plants, 24 of which are in nonattainment areas, and
Illinois has the majority with 15. Of 18 synthetic pharmaceutical plants in
EPA Region III, 12 are in Pennsylvania. Sixteen of the plants in Region III
are in nonattainment areas.
The remaining 37 plants (26 percent of the total) are located in the
other seven EPA regions, with distribution ranging from 1 plant each in Re-
gions VIII and X to 10 plants in Region IV. Of these 37 plants, 11 are in
attainment areas for oxidants, and 26 are in nonattainment areas.
Table 1 shows the breakdown of plants by EPA region; Table 2 shows the
breakdown by state. Appendix A provides a listing of all synthetic pharmaceu-
tical plants, designating county, air quality control region, and attainment/
nonattainment area status. These plants produce a variety of synthetic chemi-
cals. Appendix B lists most of the companies and their synthetically manufac-
tured products.
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TABLE 1. DISTRIBUTION OF SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY EPA REGIONS
Region
I
II
III
IV
V
VI
VII
VIII
IX
X
Total s
Total
4
58
18
10
27
5
9
1
7
1
140
Number of plants
Attainment
0
8
2
6
3
1
4
0
0
0
24
Nonattainment
4
50
16
4
24
4
5
1
7
1
116
10
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TABLE 2. DISTRIBUTION OF SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
State
Alabama
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Mary! and
Massachusetts
Michigan
Mississippi
Missouri
New Jersey
New York
North Carolina
Ohio
Pennsylvania
Tennessee
Texas
Virginia
Washington
West Virginia
Wisconsin
Puerto Rico
Number of plants
Attainment
0
1
0
0
0
0
1
2
0
3
1
0
0
0
0
0
0
1
3
0
0
1
0
0
1
0
1
0
1
0
8
Nonattainment
1
0
7
1
3
1
0
0
15
1
0
2
1
1
1
1
5
0
3
27
23
0
1
12
3
3
0
1
2
1
0
11
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Projected Growth
The economic outlook for the pharmaceutical industry is generally posi-
tive. ^ Although some patent expirations and governmental efforts at cost
containment may threaten the industry, the profitability of developing new
products will foster the industry's interests.
In all probability, growth in dollars will exceed growth in unit volume
by several percent. Dollar sales should escalate by more than 10 percent per
year and possibly by as much as 12 percent. Based on a compounded rate of 12
percent, the U.S. market will grow from $9.3 billion in 1978 to more than $18
billion in 1984. This assumes an annual inflationary impact of 5 to 6 percent.
The projected growth outlook provides a strong argument for smaller
companies to actively seek acquisition and merger situations. The larger
companies would likely be advised to alter their operations to include joint
ventures and licensed products. Leading companies could have difficulty
generating from internal sources the sales volume required merely to keep pace
with market growth.
12
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SECTION 3
CONTROL TECHNIQUES AND FACTORS
AFFECTING ENFORCEMENT
SUMMARY OF RACT REGULATIONS
On the basis of the control technology specified in the CTG, EPA devel-
oped a model regulation affecting emission sources of facilities manufacturing
synthesis Pharmaceuticals. The regulation applies to all sources of VOC such
as reactors, distillation units, dryers, storage and transfer operations, fil-
ters, crystallizers, and centrifuges, that emit 15 Ib/day or more. Pharmaceu-
tical production activities excluded from the regulation are fermentation
extraction of organic chemicals from vegetable materials or animal tissues
and formulation and packaging of the product.
The owner or operator of a facility manufacturing synthetic pharmaceuti-
cals must reduce VOC emissions by adding suitable controls or applying main-
tenance practices, discussed in the following paragraphs.
Where surface condensers are to be used as the control device, the outlet
gas temperature must not exceed the following values (all vapor pressures
measured at 20°C):
-25°C when condensing VOC of vapor pressure greater than 40 0
kPa (5.8 psi).
-15°C when condensing VOC of vapor pressure greater than 20.0
kPa (2.9 psi).
0°C when condensing VOC of vapor pressure greater than 10 0
kPa (1.5 psi).
10°C when condensing VOC of vapor pressure greater than 7.0
kPa (1.0 psi).
25°C when condensing VOC of vapor pressure greater than 3.5
kPa (0.5 psi).
The regulation for air dryers and production equipment exhaust systems
states reduction of the VOC emissions by at least 90 percent if emissions are
at least 150 kg/day (330 Ib/day). Otherwise, emissions shall be reduced to 15
kg/day (33 Ib/day).
The owner or operator of the facility must also provide a vapor balance
system or equivalent control that is at least 90 percent efficient in reducing
13
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VOC emissions from truck or rail car deliveries to storage tanks with capaci-
ties greater than 7500 liters (2000 gallons) that store VOC with vapor pres-
sures greater than 28.0 kPa (4.1 psi) at 20°C. Installation of pressure/
vacuum conservation vents set at ±0.2 kPa is also required on all storage
tanks that store VOC with vapor pressures greater than 10.0 kPa (1.5 psi) at
20°C.
All centrifuges, rotary vacuum filters, and other filters having an
exposed liquid surface must be enclosed if the liquid exerts a total VOC vapor
pressure of 3.50 kPa (0.5 psi) or more at 20°C. Covers must be installed on
all in-process tanks that contain VOC. All observed leakage of running or
dripping VOC is to be corrected the first time the equipment is off-line long
enough to repair the source of leak.
Final compliance is by December 31, 1982. The owner or operator may
propose an alternative compliance schedule before September 15, 1980. These
dates assume promulgation on July 1, 1980. Final compliance for the alterna-
tive schedule must be achieved as quickly as possible and 'before the date for
attainment of photochemical oxidant standards.
Continuous monitoring of the following parameters is required if add-on
control equipment is used: exhaust gas temperature of all incinerators,
temperature rise across a catalytic incinerator bed, and breakthough of VOC on
a carbon adsorption unit. States may require other continuous monitoring or
recording devices and also may request an emissions test to show compliance
with this regulation. Test procedures must be consistent with the EPA Guide-
line Series document, "Measurement Of Volatile Organic Compounds.
CONTROL TECHNOLOGIES
The model regulation for control of VOC emissions from manufacture of
synthesis Pharmaceuticals is based on control techniques specified in the CTG
document. Briefly, these techniques specify the use of condensers, scrubbers,
carbon adsorption systems, incinerators, or a combination of controls.
Condensers
Condensers are widely used to recover solvent from reactors, distillation
units, extractors, separators, and dryers. In a surface condenser, the most
common type, heat is transferred across a tube wall that separates the vapor
and coolant. The coolant is not contaminated with the condensed VOC; thus it
may be directly reused. The type of coolant depends on the degree of cooling
required and is usually either water or brine. Freon may be used to provide
lower cooling temperatures.
Condensation begins when the air/vapor temperature is low enough that the
vapor pressure of the VOC is equal to its partial pressure. The point at
which condensation first occurs is called the dew point. As the vapor is
cooled further, condensation continues and the partial pressure stays equal to
the vapor pressure. The less volatile a compound, the lower the amount that
can remain vaporized at a -given temperature.
14
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When the solvent vapor concentration is high, condensation is relatively
easy; condensers are a less attractive control option when the gas stream is
dilute or far from saturation. In such cases, considerable cooling is re-
quired to condense the VOC. .Condenser performance (lower temperature limit)
may also be limited if one of the condensables freezes. Frozen water or VOC
on the condenser tubes or walls renders them ineffective as heat transfer sur-
faces. The CTG outlines a method of estimating the removal efficiency of a
condenser. J
Scrubbers
Scrubbers are designed to provide intimate contact between the scrubbing
liquid and the gaseous pollutant which promotes mass transfer between the
phases. The liquid absorbs the gas because of the preferential solubility of
the gas or gases in the liquid. Absorption is important in the pharmaceutical
industry because many VOC's or other chemicals used are soluble in water or in
caustic or acidic solutions. Scrubbers are of the venturi, packed tower
plate or tray tower, and spray tower types. Scrubbing is applied to reduce
emissions from reactors, distillation equipment, process and storage tanks
centrifuges, filters, crystal!izers, dryers, and fugitive sources.
Jhe VOC concentration in a scrubber exhaust is related to the equilibrium
partial pressure of the DoHutant(s) in the scrubbing medium. For a given
unit, overall scrubber efficiencies are influenced by intimacy of contact
between gas and liquid, operating temperature, concentration of the pollutant
in the gas stream, concentration of the pollutant in the liquid scrubbing
medium, and gas and liquid flow rates. '
Carbon Adsorbers
Activated carbon adsorption has been found effective in controlling VOC
emissions because many organics are easily adsorbed onto activated carbon
Because the adsorbed compounds have practically no vapor pressure at ambient
temperatures, a carbon adsorption system is particularly suited to streams
with low VOC concentrations.
Activated carbon for adsorption of organic vapors should have a sponqe-
like structure with a large internal surface area (500 to 1000 m2/g) Pores
within the carbon structure should be about the size of the molecules to be
adsorbed. Activation of the carbon consists of subjecting it to steam and/or
air at high temperatures to remove strongly adsorbed hydrocarbons by oxidation
or desorption.
A carbon adsorption system initially removes almost 100 percent of a VOC
contaminant; then,as saturation of the carbon progresses through the bed the
VOC will break through the bed into the system exhaust. At or before break-
through, the carbon must be regenerated and another adsorption cycle must be
started. During regeneration the VOC are desorbed with steam, warm air, inert
gas, or vacuum. Stripped vapors are usually condensed or adsorbed. Possible
VOC emission points are condensate receivers, water (condensed steam) drains
and wastewater treatement basins. '
15
-------
The amount of material adsorbed on a carbon bed depends on the type of
activated carbon used; the VOC characteristics; the VOC concentration; and the
temperature, pressure, and humidity of the system. Overall VOC removal effi-
ciencies depend on the system design. Units can be designed and operated at
removal efficiencies well above 90 percent. Carbon adsorbers can be used to
control VOC with boiling points up to 250°C and concentrations ranging from 1
ppm to 40 percent. Maximum inlet temperature of the VOC-containing stream
should not exceed 140°C.
Incinerators
Incinerators and afterburners oxidize VOC in waste gases to form carbon
dioxide and water. The two types of vapor incinerators in use are thermal and
catalytic.
A thermal incinerator depends on direct flame contact and high tempera-
tures to burn the combustible materials. Supplemental fuel is required to
combust dilute VOC streams. Factors that influence the efficiency of com-
bustion are temperature, degree of mixing, residence time in the combustion
chamber, and type of VOC combusted. Destruction efficiency increases as the
VOC concentration or the operating temperature is increased.
A catalytic incinerator preheats a contaminated waste stream to a prede-
termined temperature (usually lower than in thermal incineration) and promotes
further oxidation by contacting the VOC with a catalyst. The efficiency of
catalytic incineration is a function of the surface area of the catalyst,
catalyst type, uniformity of gas flow through the bed, VOC type, oxygen con-
centration, volume of gas per unit of catalyst, and operating temperature of
the unit. Periodic catalyst replacement is required because efficiency de-
creases with use of the unit. In addition, some compounds may poison the
catalyst and render it ineffective. The efficiency of a catalytic incinerator
depends strongly on the amount of the catalyst in the unit. Because of the
high catalyst volume required for very high conversion (>98 percent) catalytic
incineration is generally uneconomical.
Incinerators are not widely used to control vapor organic emissions from
synthesis drug production. The primary reasons are high operating costs,
variability of waste gases that would be ducted to an incinerator, and opera-
tion by batch processes. Fluctuating flows and VOC concentrations may hamper
safe and efficient operation. Heat recovery is impractical because the incin-
erators would be relatively small and would generally run less than 24 hours
per day. In addition, some compounds such as chlorinated organics, amines,
and sulfinated organics can corrode the incinerator.
FACTORS AFFECTING ENFORCEMENT
Problems related to enforcement and compliance with the model regulation
include the exemption of certain manufacturing processes, the provisions
regarding source size, determination of compliance schedules, and application
of the bubble concept.
16
-------
The model regulation specifically exempts fermentation, extraction of
organic chemicals from vegetable materials or animal tissues, and formulation
and packaging processes. The regulation indicates that manufacturers of
pharmaceutical products by chemical synthesis emit most of the VOC in the
industry, but many VOC are also used and emitted by the exempted pharmaceuti-
cal manufacturing processes. In fact, many pharmaceutical companies use more
than one manufacturing process at the same facility over the course of a year
Sources should not be allowed to control VOC emissions from chemical synthesis
operations at a facility that operates such processes for 3 months and to
exempt VOC emissions from other processes that might operate 9 months. State
permit review may solve this problem.
_ Recent guidance for OAQPS has begun to clarify the source size provision
The criterion of 15 Ib or more of VOC emission per day applies to each vent
and not the process equipment (i.e., each reactor, distillation unit, dryer'
storage and process tank, VOC transfer, filter, crystallizer, centrifuge). It
does not apply to the total of emissions from all the sources in a manufac-
turing process. The new guidance covers vents from storage tanks, centri-
fuges, and filters having an exposed liquid surface.
However, for further clarification it should be reworded to apply only to
sources that emit 15 Ib per day after the application of air pollution control
equipment. This concept also agrees with the recent redefinition of "poten-
tial to emit" in the case of Alabama Power. A policy statement is planned by
OAQPS on this subject. Many sources are already equipped with state-of-art
air emission controls, and mass VOC emissions may already be below the exclu-
sion level.
Determining compliance with the regulation will be difficult because the
only methods currently available to measure VOC emissions are by solvent usage
and/or by correct control equipment operations. The test methods cited in the
model regulation are not applicable to the emissions associated with the batch
operations predominant in this industry; these emissions are intermittent and
highly variable, and often occur at low velocities and low concentrations.
The use of alternative methods such as calculations and audits should be
defined as acceptable. Another problem is that testing and monitoring re-
quirements specify that VOC breakthrough on a carbon bed is to be continuously
monitored. The equipment for the low level of detection required can be quite
expensive.
The regulation should somewhere describe a vapor balance system for
reducing emissions during VOC deliveries. The type of delivery specified
should not eliminate any form of transportation such as barging.
Meeting the compliance schedules may pose a problem for the pharmaceuti-
cal industry. Determining compliance status and defining a compliance program
for a major synthesis pharmaceutical plant will be a lengthy task. Such a
plant contains hundreds of pieces of equipment, each of which may be a VOC
emission source. Moreover, a single source can be used for many processes,
with wide variations in the magnitude of emissions. Simply defining the scope
of the compliance effort will be a major undertaking. Compliance efforts that
require a process modification must also be approved by the Food and Drug
Administration and thus will require additional time to meet the compliance
17
-------
schedule. The model regulations provide for compliance schedule modifica-
tions, but specific guidance for this industry is needed.
Because most synthetic pharmaceutical plants contain numerous sources,
the bubble concept will be beneficial to the industry in complying with VOC
regulations. It may be advantageous to allow more stringent controls on the
large sources and less stringent controls on the smaller sources. All uncon-
trolled VOC emissions must be quantified, however, before the bubble concept
can be applied.
18
-------
SECTION 4
RECOMMENDATIONS FOR FURTHER INVESTIGATION
Areas where further investigation could facilitate the enforcement of VOC
regulation by regional, state, and local agencies include determining VOC
emissions, clarifying the bubble concept, and extending compliance schedules.
DETERMINING VOC EMISSIONS
Emissions in the synthetic pharmaceutical industry vary greatly because
of the nature of batch operations and also because many chenvical synthesis
plants may also produce pharmaceutical products by fermentation and extraction
of organic materials using the same process equipment. Emissions (particu-
larly those subject to control by the VOC regulations) usually vary from month
to month and from year to year. Guidelines should be established for a method
of determining potential and controlled emissions.
CLARIFYING THE BUBBLE CONCEPT
The bubble concept is beneficial to the chemical synthesis pharmaceutical
industry. Clarification is needed on an overall control efficiency that can
be applied plantwide for application of the bubble concept. Presently the
control strategies for reduction of VOC emissions from air dryer and produc-
tion equipment exhaust systems require 90 percent reduction if VOC emissions
are at least 150 kg/day or require control to 15 kg/day if VOC emissions are
less than 150 kg/day. A standard percentage reduction applicable to the
emission sources in the plant would enhance application of the bubble concept.
EXTENDING COMPLIANCE SCHEDULES
Process modifications may delay compliance or extend the time required to
install add-on controls because the Food and Drug Administration must approve
all modifications. Some guidance should be prepared for situations where
compliance will be delayed by process modifications. A standard method should
be established for obtaining extensions required by the need for FDA approval
19
-------
-------
APPENDIX A
SYNTHETIC PHARMACEUTICAL PLANTS
BY LOCATION
This appendix provides a listing of all synthetic pharmaceutical plants,
first in a table by region; then in a table by state. The county and attain-
ment/nonattainment area status is given.
A-l
-------
TABLE A-l.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
IN REGION I
State
Connecticut
Maine
Massachusetts
New Hampshire
Rhode Island
Vermont
Total s
No. of plants
3
0
1
0
0
0
4
Plants in
attainment areas
0
0
0
0
0
0
0
Plants in
nonattainment areas
3
0
1
0
0
0
4
A-2
-------
TABLE A-2.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
Connecticut
CPC International
Wallingford
Pfizer, Inc.
Groton
Sterling Drug, Inc.
Glenbrook
Massachusetts r ".
Astra Pharmaceutical
Worcester
County
New Haven
New London
Fairfield
Worcester
AQCR
42
41
43
118
Status
Nonattainment
Nonattainment
Nonattainment
Nonattainment
A-3
-------
TABLE A-3
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
IN REGION II
State
New Jersey
New York
Puerto Rico
Virgin Islands
Total s
.No. of plants
27
23
8
0
58
Plants in
attainment areas
0
0
8
0
8
Plants in
nonattainment areas
27
23
0
0
50
A-4
-------
TABLE A-4.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
NEW JERSEY
Aceto Chemical Company, Inc
Carlstadt
American Cyanamid
Bound Brook
Beecham, Inc.
Piscataway
Ciba Geigy Corporation
Summit
CPC International
Lyndhurst
CPC International
Newark
Diamond Shamrock Corp.
Harrison
Ganes Chemicals, Inc.
Carlstadt
Ganes Chemicals, Inc.
Pennsville
Gulf Oil Corporation
Berkeley Heights
Hexcel Corporation
Lodi
Hoffman-LaRoche, Inc.
Belvidere
Hoffman-LaRoche, Inc.
Nutley
Hummel Chemical Company
South Plainfield
Merck and Company, Inc.
Hawthorne
Merck and Company, Inc.
Rahway
Miles Laboratories, Inc.
Clifton
County
Bergen
Somerset
Middlesex
Union
Bergen
Essex
Hudson
Bergen
Salem
Union
Bergen
Warren
Essex
Middlesex
Passaic
Union
Passaic
AQCR
43
43
43
43
43
43
43
43
45
43
43
151
43
43
43
43
43
Status
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
(continued)
A-5
-------
TABLE A-4. (continued)
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
NEW JERSEY (continued)
Napp Chemicals, Inc.
Lodi
N. L. Industries, Inc.
Bayonne
Norda, Inc.
Newark
Rhone-Paul enc, Inc.
New Brunswick
Richardson-Merrell , Inc.
Phillipsburg
Southland Corporation
Great Meadows
Squibb Corporation
New Brunswick
Stauffer Chemical Company
Edison
Sterling Drug, Inc.
Trenton
Tenneco Chemicals, Inc.
Garfield
NEW YORK
Accurate Chemical and Scientific
Corporation
Hicksville
Aceto Chemical Company, Inc.
Flushing
Aceto Chemical Company, Inc.
Long Island City
American Cyanamid
Pearl River
American Lecithin Company
Woods ide
County
Bergen
Hudson
Essex
Middlesex
Warren
Warren
Middlesex
Middlesex
Mercer
Bergen
Nassau
New York
New York
Rock! and
Queens
AQCR
43
43
43
43
151
151
43
43
161
43
43
43
43
43
43
Status
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
(continued)
A-6
-------
TABLE A-4. (continued)
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
NEW YORK (continued)
Arenol Chemical Corporation
Long Island City
Atomergic Chemetals Corp.
Plainview
Bristol-Myers Company
Syracuse
Ciba Geigy Corporation
Suffern
DDR Pharmaceutical Corporation
Cop i ague
Eastman Kodak Company
Rochester
E. I. DuPont De Nemours and Co. , Inc.
Garden City
General Foods Corporation
White Plains
Heterochemical Corporation
Valley Stream
Hexagon Laboratories, Inc.
Bronx
Nepera Chemical Co. , Inc.
Harriman
Norton-Norwich Products, Inc.
Norwich
Pennwalt Corporation
Buffalo
Pfizer, Inc.
Brooklyn
Polychemical Laboratories, Inc.
Bronx
RSA Corporation
Ardsley
County
New York
Nassau
Onondaga
Rock! and
Suffolk
Monroe
Nassau
Westchester
Nassau
New York
Orange
Chenango
Erie
New York
New York
Westchester
AQCR
43
43
158
159
43
160
43
43
43
43
161
163
162
43
43
43
Status
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattai nment
Nonattainment
Nonattainment
(continued)
A-7
-------
TABLE A-4. (continued)
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
NEW YORK (continued)
RSA Corporation
Bronx
Sterling Drug, Inc.
Rensselaer
PUERTO RICO
Abbott Labs
Barceloneta
E. I. DuPont Oe Nemours and Company
Carolina
Eli Lilly and Company
Carolina
Merck and Company, Inc.
Barceloneta
Norton-Norwich Products, Inc.
Manati
Smith Kline
Guyana
Squibb Corporation
Humacao
Upjohn Company
Arecibo
County
New York
Rensselaer
AQCR
43
161
244
244
244
244
244
244
244
244
Status
Nonattainment
Nonattainment
Attainment
Attainment
Attainment
Attainment
Attainment
Attainment
Attainment
Attainment
A-8
-------
TABLE A-5.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
IN REGION III
State
Delaware
Maryland
Pennsylvania
Virginia
West Virginia
Washington, D.C.
Totals
No. of plants
1
1
12
1
3
0
18
Plants in
attainment areas
0
0
0
1
1
0
2
Plants in
nonattainment areas
1
1
12
. 0
2
0
16
A-9
-------
TABLE A-6.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
DELAWARE
ICI Americas, Inc.
Newark
MARYLAND
Becton, Dickinson, Inc.
Baltimore
PENNSYLVANIA
American Home Products
Paol i
Beecham, Inc.
Myerstown
Carroll Products, Inc.
Philadelphia
Glyco Chemicals, Inc.
Williamsport
Koppers Company, Inc.
Petrol i a
Merck and Company, Inc.
Danville
Pharmachem Corporation
Bethlehem
Ruetgers-Nease Chemical Co. , Inc.
State College
Smith-Kline Corporation
Philadelphia
Smith-Kline Corporation
Swedeland
Tyler Corporation
Tamaque
West Chemical Products
Eighty Four
County
New Castle
Baltimore
Chester
Lebanon
Philadelphia
Lycomi ng
Butler
Montour
Northampton
Centre
Philadelphia
Montgomery
Schuylkill
Washington
AQCR
45
115
45
196
45
195
197
195
151
195
45
45
151
197
Status
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattai nment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
(continued)
A-10
-------
TABLE A-6. (continued)
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
VIRGINIA
Merck and Company, Inc.
Elkton
WEST VIRGINIA
American Cyanamid
Willow Island
Monsanto Company
Nitro
Union Carbide
Charleston
County
Rockingham
Pleasants
Kanawha
Kanawha
AQCR
226
179
234
234
Status
Attainment
Attainment
Nonattainment
Nonattainment
A-11
-------
TABLE A-7.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
IN REGION IV
State
Alabama
Fl ori da
Georgia
Kentucky
Mississippi
North Carolina
South Carolina
Tennessee
Total s
No. of plants
1
1
2
1
1
, 1
0
3
10
Plants in
attainment areas
0
1
2
0
1
1
0
1
6
Plants in
nonattainment areas
1
0
0
1
0
0
0
2
4
A-12
-------
TABLE A-8.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
ALABAMA
Degussa Corporation
Theodore
FLORIDA
SCM Corporation
Gainesvil le
GEORGIA
Dow Chemical U.S.A.
Gainesville
Merck and Company, Inc.
Albany
KENTUCKY
Diamond Shamrock Corporation
Louisville
MISSISSIPPI
Sterling Drug, Inc.
Gulfport
NORTH CAROLINA
Burroughs Wellcome Company
Greenville
- TENNESSEE
Chattem, Inc.
Chattanooga
Eastman Kodak
Kingsport
Syntex Corporation
Newport
County
Mobile
Alachua
Hall
Dougherty
Jefferson
Harrison
Pitt
Hami 1 ton
Sullivan
Cocke
AQCR
5
49
57
59
78
5
168
55
207
207
Status
Nonattainment
Attainment
Attainment
Attainment
Nonattainment
Attainment
Attainment
Nonattainment
Nonattainment
Attainment
A-13
-------
TABLE A-9.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
IN REGION V
State
Illinois
Indiana
Michigan
Minnesota
Ohio
Wisconsin
Totals
No. of plants
15
4
6
'o
1
1
27
Plants in
attainment areas
0
3
0
0
0
0
3
Plants in
nonattainment areas
15
1
6
0
1
1
24
A-14
-------
TABLE A-10.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
ILLINOIS
Abbott Laboratories
North Chicago
A. E. Staley Manufacturing
Decatur
Chemtek Laboratories
AT sip
Dawe's Laboratories, Inc.
Chicago Heights
Douglas Laboratories, Inc.
Chicago Heights
G. D. Searle and Company
Skokie
Henkel Corporation
Kankakee
I no lex Corporation
Park Forest South
Lonza, Inc.
Mapleton
Minnesota Mining and Manufacturing
Company
Cordova
North American Philips Corporation
Waukegan
Organics, Inc.
Chicago
Pfanstiehl Laboratories, Inc.
Waukegan
Revlon, Inc.
Kankakee
Vitamins, Inc.
Chicago
INDIANA
Eli Lilly and Company
Lafayette
County
Lake
Macon
Cook
Cook
Cook
Cook
Kankee
Will
Peoria
Rock Island
Lake
Cook
Lake
Kankakee
Cook
Tippecanoe
AQCR
67
75
67
67
67
67
67
67
65
69
67
67
67
67
67
84
Status
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattai nment
Nonattainment
Nonattainment
Nonattainment
Attainment
(continued)
A-15
-------
TABLE A-10. (continued)
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
INDIANA
International Minerals and Chemical
Corporation
Terre Haute
Pfizer, Inc.
Terre Haute
Reilly Tar and Chemical Corporation
Indianapolis
MICHIGAN
Anderson Development Company
Adrian
Dow Chemical U.S.A.
Midland
Hexcel Corporation
Zeeland
Hoffman- LaRoche, Inc.
Muskegon
Upjohn Company
Kalamazoo
Warner-Lambert Company
Holland
OHIO
Sterling Drug, Inc.
Cincinnati
WISCONSIN
Oscar Mayer and Company
Madison
County
Vigo
Vigo
Marion
Lenawee
Midland
Ottawa
Muskegon
Kalamazoo
Ottawa
Hamilton
Dane
AQCR
.„
84
84
80.
125
122
122
122
125
122
79
240
Status
Attainment
Attainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
A-16
-------
TABLE A-11.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
IN REGION VI
State
Arkansas
Louisiana
New Mexico
Oklahoma
Texas
Totals
=^======
No. of plants
1
1
0
0
3
5
===^=^=====^==^
Plants in
attainment areas
1
0
0
0
0
1
'
Plants in
nonattainment areas
0
1
0
0
3
4
A-17
-------
TABLE A-12.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
County
AQCR
Status
ARKANSAS
Diamond Shamrock Corporation
Van Buren
LOUISIANA
Monsanto Company
Luling
TEXAS
Dow Chemical U.S.A.
Freeport
E. I. DuPont De Nemours and Co., Inc.
Beaumont
Union Carbide Corporation
Texas City
Crawford
St. Charles
Brazoria
Jefferson
Galveston
17
106
216
106
216
Attainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
A-18
-------
TABLE A-13.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
IN REGION VII
State
Iowa
Kansas
Missouri
Nebraska
Totals
No. of plants
1
2
6
0
9
Plants in
attainment areas
1
0,
3
0
4
Plants in
nonattainment areas
o
2
3
0
5
A-19
-------
TABLE A-14.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE .
Name and location
IOWA
Salisbury Labs
Charles City
KANSAS
Daitom, Inc.
Kansas City
North American Phillips Corporation
Kansas City
MISSOURI
American Cyanamid
Hannibal
Mallinckrodt, Inc.
St. Louis
Monsanto Company
St. Louis
Syntex Corporation
Springfield
Syntex Corporation
Verona
West Chemical Products, Inc.
Kansas City
County
Floyd
Wyandotte
Wyandotte
Marion
St. Louis
St. Louis
Greene
Lawrence
Jackson
AQCR
89
94
94
137
70
70
139
139
94
Status
Attainment
Nonattainment
Nonattainment
Attainment
Nonattainment
Nonattainment
Attainment
Attai nment
Nonattainment
A-20
-------
TABLE A-15.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
IN REGION VIII
State
Colorado
Montana
North Dakota
South Dakota
Utah
Wyomi ng
Totals
No. of plants
1
0
0
0
0
0
1
Plants in
attainment areas
0
0
0
0
0
0
0
Plants in
nonattainment areas
1
0
0
0
0
0
1
A-21
-------
TABLE A-16.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
COLORADO
Shell Chemical Company
Denver
County
Denver
AQCR
36
Status
Nonattainment
A-22
-------
TABLE A-17.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
IN REGION IX
State
Arizona
California
Hawaii
Nevada
American Samoa
Guam
Totals
No. of plants
0
7
0
0
0
0
7
Plants in
attainment areas
0
0
0
0
0
0
0
Plants in
nonattainment areas
0
7
0
0
0
0
7
A-23
-------
TABLE A-18.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
CALIFORNIA
Alameda Laboratorties
Los Angeles
Beckman Instruments, Inc.
Palo Alto
Belport Company, Inc.
Camari 11 o
Hill Brothers Chemical Company
City of Industry
ICI Americas, Inc.
Pasadena
International Rectifier Corporation
Long Beach
Minnesota Mining and Manufacturing
Company
Northridge
County
Los Angeles
Santa Clara
Ventura
Los Angeles
Los Angeles
Los Angeles
Los Angeles
AQCR
24
30
24
24
24
24
24
Status
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
Nonattainment
A-24
-------
TABLE A-19.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
IN REGION X
State
Alaska
Idaho
Oregon
Washington
Total s
No. of plants
0
0
0
1
1
Plants in
attainment areas
0
• o
0
0
0
Plants in
nonattai nment areas
0
0
0
1
1
A-25
-------
TABLE A-20.
OPERATING SYNTHETIC PHARMACEUTICAL MANUFACTURING PLANTS
BY STATE
Name and location
WASHINGTON
Stansbury Chemical Company, Inc.
Seattl e
County
King
AQCR
229
Status
Nonattainment
A-26
-------
APPENDIX B
SYNTHETIC PHARMACEUTICAL PLANTS
BY TYPE OF CHEMICAL PRODUCED
This appendix provides a listing of synthetic pharmaceutical plants and
their synthetically manufactured products.
B-l
-------
ABBOTT LABORATORIES
NORTH CHICAGO, ILLINOIS 60064
Ammonium heparin
Arsanilic acid
Butabarbital
Butabarbital, sodium
Butyl aminobenzoate
para-N.N-Dichlorosulfamylbenzoic acid
Erythromycin
Erythromycin lactobionate
Erythromycin phosphate
Erythromycin stearate
Fumagi11i n
Heparin
Hydrochlorothiazide
Lithium heparin
Menadione
Menadione sodium bisulfite
Methapyrilene fumarate
Methapyrilene hydrochloride
Pentobarbital, sodium
Pramoxine hydrochloride
Pentobarbital, sodium
Pramoxine hydrochloride
Sodium heparin
Succinylcholine chloride
Thiopental, sodium
Tubocurarine chloride
*Plant also manufactures 13 other chemicals.
Erythromycin
ABBOTT LABORATORIES
BARCELONETA, PUERTO RICO 00617
ACCURATE CHEMICAL AND SCIENTIFIC CORPORATION
HICKSVILLE, NEW YORK 11801
Hepari n
Metrizoate, meglumine
Metrizoate, sodium
*Plant also manufactures 27 other chemicals and products.
B-2
-------
ACETO CHEMICAL CO.
FLUSHING, NEW YORK
, INC.
11368
Thimerosal
*Plant also manufactures 5 other chemicals.
ACETO CHEMICAL CO., INC.
CARLSTADT, NEW JERSEY 07072
Acetylglycol sal icylate
Ambutonium bromide
Aminobenzoic acid
Butyl aminobenzoate
Ethyl p-aminobenzoate
Glyceryl guaiacolate
N-(2-Hydroxyethyl) gentisamide
Isobuty1-p-ami nobenzoate
Salicylic acid, 3,3,5-timethylcyclohexyl
Tetracaine hydrochloride
ester
*Plant also manufactures 111 other chemicals.
ACETO CHEMICAL CO., INC.
LONG ISLAND CITY, NEW YORK 11101
Phenypropanolamine hydrochloride
Tolazoline hydrochloride
*Plant also manufactures 7 other chemicals.
ALAMEDA LABORATORIES, INC.
LOS ANGELES, CALIFORNIA 90001
Chlorpromaxine hydrochloride
Diphenoxylate
imipramine
Phendimetrazine bitartrate
Prochlorperazine, base
Pseudoephedrine hydrochloride
Trifluoperazine hydrochloride
Triprocidine hyrdochloride
*Plant also manufactures 13 other chemicals.
B-3
-------
AMERICAN CYANAMID COMPANY
BOUND BROOKS, NEW JERSEY 08805
Beta naphthol
Diethylcarbamazine citrate
Dithiouracil
Salicylazosul fapyridine
Sulfabenzamide
Sulfachloropyrazine, sodium
Sulfadiazine
Sulfamerazine
Sulfamethazine
Sulfamethizole
Sulfapyridine
Thiouracil
Tridihexethyl chloride
Trihexyphenidyl hydrochloride
*Plant also manufactures 151 other chemicals and products.
AMERICAN CYANAMID COMPANY
HANNIBAL, MISSOURI 63401
Chlortetracycline
*Plant also manufactures 3 other chemicals.
AMERICAN CYANAMID COMPANY
PEARL RIVER, NEW YORK 10965
Chiortetracycli ne hydrochlori de
Cyanocobalamin (intrinsic factor concentrate)
Demeclocycline hydrochloride
Minocycline hydrochloride
Nystati n
Tetracycline hydrochloride
AMERICAN CYANAMID COMPANY
WILLOW ISLAND, WEST VIRGINIA
Chiortetracycli ne
Bis (m-nitrophenyl) disulfide
Choline bitartrate
Choline citrate
Choline dihydrogen citrate
*Plant also manufactures 27 other chemicals and products.
B-4
-------
AMERICAN HOME PRODUCTS CORPORATION
PAOLI, PENNSYLVANIA 19301
Ampicillin
Ampicillin, sodium
Carphenazine maleate
Cyclandelate
Dicloxacillin, sodium
Ethoheptazine citrate
Meperidine hydrochloride
Nafcillin, sodium
Norgestrel
Oxazepam
Oxethazaine
Penicillin G, benzathine
Penicillin G, potassium
Penicillin G, proclaine
Phenoxymethylpenicillin, potassium
Promazine hydrochloride
Promethazine hydrochloride
Sodium mercaptomerin
AMERICAN LECITHIN COMPANY
WOODSIDE, NEW YORK 11377
Lecithin
*Plant also produces 2 other types of products.
ANDERSON DEVELOPMENT COMPANY
ADRIAN, MICHIGAN 49221
m-Cresyl acetate
*Plani also manufactures 25 other chemicals and products.
ARENOL CHEMICAL CORPORATION
LONG ISLAND CITY, NEW YORK 11101
Methenamine mandelate
B-5
-------
ASTRA PHARMACEUTICAL PRODUCTS, INC.
WORCESTER, MASSACHUSETTS 01606
Etidocaine
Etidocaine hydrochloride
Lidocaine
Prilocaine
Prllocaine hydrochloride
Terbutaline sulfate
ATOMERGIC CHEMETALS CORPORATION
PLAINVIEW, NEW YORK 11803
Acetazolamide
Allopurinol
Amygpalin
Aspartic acid
Bisacodyl
Bupiyacaine
Calcium phytate
Carbetapentane citrate
Carisoprodol
Chlorobutanol
Chlorothiazide
Chlorpromazine base
Diazepam
Ferrous fumarate
Flurazepam hydrochloride
Hydrochlorothiazide
Hydroxyzine hydrochloride
lossorbide dinitrate
Lidocaine
Mefenamic acid
Mepivacaine
Oxazepam
Phenaceti n
Propylthiouracil
Terpin hydrate
Thimerosal
Vitamin B15, sodium salt
Vitamins (unspecified)
*Plant also manufactures 20 other chemicals and products.
BECKMAN INSTRUMENTS, INC.
PALO ALTO, CALIFORNIA 94304
Parathyroid hormone
*Plant also manufactures 51 other chemicals and products.
B-6
-------
BECTON, DICKINSON, INC.
BALTIMORE, MARYLAND 21201
Indocyanine green
Merbromin
Phenolsulfonphthal ei n
Sal icy! alcohol
*Plant also manufactures 6 other chemicals.
BEECHAM, INC.
PISCATAWAY, NEW JERSEY 08854
Amoxicillin
Ampicillin
Carbenicillin
Cloxacillin, sodium
Dicloxacillin, sodium
Methicillin, sodium
Ticarcillin
BEECHAM, INC.
MYERSTOWN, PENNSYLVANIA 17067
Arsanilic acid
Piperazine monhydrocloride, neutral solution
*P1ant also manufactures 3 other chemicals.
THE BELPORT COMPANY, INC.
CAMARILLO, CALIFORNIA 93010
Epinephrine hydrpchloride (racemic)
Epinephrine (levo)
BRISTOL-MYERS COMPANY
SYRACUSE, NEW YORK 13201
Amikacin
Amikacin sulfate
Amoxicillin trihydrate
Ampicillin, sodium
Amp i c i11i n, tri hydrate
Butrophanol tartrate
Cephapirin
Cephapirin, sodium
Cloxacillin, sodium
Dicloxacillin, sodium
B-7
-------
BRISTOL-MYERS COMPANY (CONTINUED)
Hetacillin
Hetacillin, potassium
Hydrof1umethi azi de
Kanamycin sulfate
Methicillin, sodium
Mitomycin C
Oxacillin, sodium
Phenethicillin, potassium
Phenoxymethyl penicillin, potassium
Pheny Hoi examine citrate
Rolitetracycline nitrate
Tetracycline
Tetracycline hydrochloride
Tetracycline pho'sphate complex
BURROUGHS WELLCOME CO.
GREENVILLE, NORTH CAROLINA
Allopurino
2-Amino-6-Benzylthiopurine
6-Anilinopurine
Bethanidine sulfate
Busulfan
Butoxamine hydrochloride
6-Carboxypuri ne
6-Chloropurine
6-Cyanopurine
2, 6-Diaminopurine
Diaveridine
Digoxin
6-Dimethylami nopuri ne
6-Iodopurine
Mercaptopurine
6-Mercaptopurine riboside
6-Methylmercatopurine
Pyrimethamine
Thoguanine
Thiopurino
Trimethoprim
Tripro!idine
*Plant also manufactures 1 other chemical.
27834
B-8
-------
CARROLL PRODUCTS, INC.
PHILADELPHIA, PENNSYLVANIA 19132
All antoin
Allantoin N-acetyl DL-methionine
Allantoin polygalacturonic acid
*Plant also manufactures 7 other chemicals.
CHATTEM, INC.
CHATTANOOGA, TENNESSEE
Aminoacetic acid
Dihydroxy aluminum aminoacetate
Theophylline sodium gylcinate
*Plant also manufactures 13 other chemicals.
CHEMLEK LABORATORIES, INC.
ALSIP, ILLINOIS 60658
Calcium pantothenate (racemic)
Calcium pantothenate (racemic) calcium chloride complex
*Plant also manufactures 1 other chemical.
CIBA-GEIGY CORPORATION
SUFFERN, NEW YORK 10901
Acenocoumarol
Biscodyl
Carbamazepine
Chlorquinaldol
Chiorthalidone
Chiorthalidone and reserpine
Crotamiton
Desipramine
Dipyridamole
Heptabarbital
Imipramine hydrochloride
Oxyphenbutazone
Phenmetrazine hydrochloride
Phenylbutazone
Phenylbutazone (other ingredients)
Sulfinpyrazone
B-9
-------
CIBA-GEIGY CORPORATION
SUMMIT, NEW JERSEY 07901
Adiphenine hydrochloride
Benzonatate
Diazepam
Dibucaine
Dibucaine hydrochlon'de
Di i odohydroxyqui n
Dimethindene maleate
Glutethimide
Guanethidine sulfate
Hydra!azine
Hydrochlorothiazide
lodobrassid
lodochlorhydroxyqui n
Methrapone
Naphazoline hydrochlon'de
Nikethamide
Sodium carboxymethylcellulose
Sulfachloropyridazine, sodium
Syrosingopine
Tripelennamine
Tripelennamine citrate
Tripelennamine hydrochloride
*Plant also manufactures 2 other chemicals.
CPC INTERNATIONAL, INC.
NEWARK, NEW JERSEY 07114
L-acetyle methadol
Bismuth subgallate
Bismuth subsalicylate
Calami ne
Candicidin
Codeine
Codeine hydrochloride
Codeine phosphate
Codeine sulfate
Diphenoxylate hydrochloride
Ethylmorphine hydrochloride
Glyceryl guaiacolate
Gramicidin
Hydrocodone bitartrate
lodoform
Meperidine hydrochloride
Methadone hydrochloride
Methocarbamol
Morphine alkaloid
Morphine hydrochloride
Morphine sulfate
B-10
-------
CPC INTERNATIONAL, INC. (CONTINUED)
Neomycin
Neomycin palmitate
Noscapine
Noscapine hydrochloride
Opium and derivatives
Papaverine hydrochloride
Sal icy!amide
Thebaine
Tyrocidine hydrochloride
Tyrothricin
*Plant also manufactures 18 other chemicals.
CPC INTERNATIONAL, INC.
LYNDHURST, NEW JERSEY
Acetaminophen
Aloin
Berberine hydrochloride
Casanthranol
Diperodon hydrochloride
Hydrastine hydrochloride
Podophyllum
Potassium estrone sulfate
Proveratrine A
Proveratrine B
Reserpine
*Plant also manufactures 9 other chemicals and products.
CPt INTERNATIONAL, INC.
WALLINGFORD, CONNECTICUT 06492
Guaiacol
*Plant also manufactures 1 other chemical.
DAITOM, INC.
KANSAS CITY, KANSAS 66106
Calcium pantothenate (dextro)
B-ll
-------
DAWE'S LABORATORIES, INC.
CHICAGO HEIGHTS, ILLINOIS 60411
Choline chloride
Menadione sodium bisulfite
Vitamin D3
*Plant also manufactures 2 other chemicals.
DDR PHARMACEUTICAL CORPORATION
COPIAGUE, NEW YORK 11726
L-dopa
*Plant also manufactures 1 other product.
DEGUSSA CORPORATION
THEODORE, ALABAMA 36582
Methionine
*Plant also manufactures 4 other chemicals.
DIAMOND SHAMROCK CORPORATION
HARRISON, NEW JERSEY 07029
Vitamin D3
*Plant also manufactures 3 other chemicals and products.
DIAMOND SHAMROCK CORPORATION
LOUISVILLE, KENTUCKY 40218
Amino acids
Antibiotics (unspecified)
Calcium pantothenate (racemic)
Choline chloride
Vitamins (unspecified)
*Plant also manufactures 1 other product.
DIAMOND SHAMROCK CORPORATION
VAN BUREN, ARKANSAS 72956
B-alanine
B-alanine, calcium salt
Calcium pantothenate (dextro)
B-12
-------
DOUGLAS LABORTORIES, INC.
CHICAGO HEIGHTS, ILLINOIS 60411
Vitamin A
Vitamin D2
Vitamin D3
*Plant also manufactures 2 other products.
DOW CHEMICAL U.S.A
FREEPORT, TEXAS 77541
Choline chloride
Piperazine, base
Piperazine dihydrochloride
Piperazine hydrochloride
*Plant also manufactures 96 other chemicals and products.
DOW CHEMICAL U.S.A.
GAINESVILLE, GEORGIA 30501
3,5-Dinitro-o-toluamide
Mietochlopramide
DOW CHEMICAL U.S.A.
MIDLAND, MICHIGAN 48640
Aspirin
Bromoform
3,5-Dinitro-o-toluamide
Metoclopramide
Phenyl sal icylate
Sal icy!ic acid
Sodium salicylate
*Plant also manufactures 146 other chemicals and products.
E.I. Du PONT De NEMOURS
BEAUMONT, TEXAS 77704
Methionine, hydroxyanalogue, calcium salt
*Plant also manufactures 1 other chemical.
B-13
-------
E.I. Du PONT De NEMOURS
GARDEN CITY, NEW YORK 11530
Hydrocodone bitartrate
Oxycodone hydrochloride
Oxymorphone hydrochloride
E.I. Du PONT De NEMOURS
CAROLINA, PUERTO RICO 00630
Anistotropine
EASTMAN KODAK COMPANY
ROCHESTER, NEW YORK 14613
D-a Tocopherol
D-a Tocopherol acetate
D-a Tocopherol acid succinate
Choline chloride
Phenolsulfonphthalei n
*Plant also manufactures 195 other chemicals and over 6000 organic chemicals.
EASTMAN KODAK COMPANY
KINGSPORT, TENNESSEE
Cellulose, oxidized
*Plant also manufactures 101 other chemicals and products.
GANES CHEMICALS, INC.
CARLSTADT, NEW JERSEY 07072
Aminophyll
Barbital
Barbital, sodium
Butabarbital
Butabarbital, sodium
Butalbital
Butalbital, sodium
Caffeine sodium benzoate
Dimenhydrinate
Diphenhydramine hydrochloride
Ethyl p-aminobenzoate
Glutethimide
Hexobarbital
Phendimethrazine tartrate
Phenobarbital
B-14
-------
GANES CHEMICALS, INC. (CONTINUED)
Phenobarbital, calcium
Phenobarbital, sodium
Phentermine hydrochloride
Phenlephrine
Phenlephrine, hydrochloride
Phenlpropanolamine hydrochloride
Potassium aminobenzoate
Probenecid
Propoxyphene hydrochloride
Pseudoephedrine, base
Pseudoephedrine hydrochloride
Pseudoephedrine sulfate
Sodium aminobenzoate
*Plant also manufactures 14 other chemicals.
GANES CHEMICALS, ING.
PENNSVILLE, NEW JERSEY 08070
Glyceryl guaiacolalte
Phenylpropane!amine hydrpcfilpride
*Plant also manufactures 14 other chemicals.
Caffeine, natural
GENERAL FOODS CORPORATION
WHITE PLAINS, NEW YORK 10625
GLYCO CHEMICALS, INC.
WILLIAMSPORT, PENNSYLVANIA 17701
Ichthammol
*Plant also manufactures 64 other chemicals.
GULF OIL CORPORATION
BERKELEY HEIGHTS, NEW JERSEY 07922
Benactyzine hydrochloride"
Dimethoxanate hydrochloride
Glyceryl guaiacolate
Mebutamate
Mephenesin
Nylidrin hydrochloride
B-15
-------
GULF OIL CORPORATION (CONTINUED)
Phenformin hydrochloride
3-Quinuclipinol
Tybamate
*Plant also manufactures 33 other chemicals.
HENKEL CORPORATION
KANKAKEE, ILLINOIS 60901
D-a Tocopherol
D-a Tocopheryl acetate
D-a Tocopheryl acid succinate
*Plant also manufactures 46 other chemicals.
HETEROCHEMICAL CORPORATION
VALLEY STREAM, NEW YORK 11580
Menadione
Menadione dimethylpyrimidino! bisulfite
Menadione sodium bisulfite
Vitamin Ks •
*Plant also manufactures 1 other chemical.
HEXAGON LABORATORIES, INC.
BRONX, NEW YORK 10475
Aspartic acid
Brompheniramine maleate
Cetylpyridinium chloride
Chlorpheniramine base
Chlorpheniramine gluconate
Chlropheniramine maleate
Dimenhydrinate
Diphenhydramine hydrochloride
Glyceryl gluaiacolate
Homatropine . ' .
Homatropine hydrobromide
Homatropine methyl bromide
Methocarbamoc
Neostigmine bromide
Neostigmine methylsulfate
Pheniramine base
Pheniramine maleate
Phentermine
Phenylephrine hydrochloride
B-16
-------
HEXAGON LABORATORIES, INC. (CONTINUED)
Prophylhexedrine
Pyrilamine maleate
Quinidine gluconate
Quinidine sulfate
Tropine
*Plant also manufactures 10 other chemicals.
HEXCEL CORPORATION
LODI, NEW JERSEY 07644
Benzalicorn urn chloride
Centalicom'urn chloride
Cetylpyridinium chloride
*Plant also manufactures 17 other chemicals.
HEXCEL CORPORATION
ZEELAND, MICHIGAN 49464
N-Butyroy1-p-Aminophenol
Dibenzylamine
N-Lauroyl-p-Aminophenol
N-Stearoyl-p-Aminophenol
*Plant also manufactures 22 other chemicals.
HILL BROTHERS CHEMICAL CO.
CITY OF INDUSTRY, CALIFORNIA
Phenolphthalein
*P1ant also manufactures 3 other chemicals and products.
HOFFMAN-LA ROCHE, INC.
BELVIDERE, NEW JERSEY 07823
Ascorbic acid
Sodium ascorbate
Sulfamethoxazole
*Plant also manufactures 2 other chemicals.
B-17
-------
HOFFMAN-LA ROCHE, INC.
NUTLEY, NEW JERSEY 07110
Acetyl sulfisoxazole
Apocarotenal
Biotin
Canthaxanthin
B-caroten
Chlordiazepoxide Hydrochlon'de
Chlorprothixene
Clidlnlum bromide
Dextromethorphan hydrobromide
Diazepam
L-dopa
Edrophonium chloride
5-Fluorouracil -
Flurazepam
Ipronidazole
Isocarboxazid
Levorphanol tartrate
Menadiol sodium diphosphate ,
Methyprylon
Neostigmine bromide
Nicotinyl alcohol tartrate
Ormetoprim
D-panthenol
Panthenol (racemic)
Phenazopyridine hydrochloride
Phenindamine tartrate
Phytonadione
Pyridostigmine bromide
Pyridoxine hydrochloride
Riboflavin
Fiboflavin-51-phosphate, sodium
Sulfadimethoxine
Sulfisoxazole
Sulfisoxazole, sodium
Thiamine hydrochloride
Thiamine mononitrate
DL-ot Tocopherol
DL-a Tocopheryl acetate
Triclobisonium chloride
Vitamin A acetate
Vitamin A alcohol
Vitamin A palmitate
*Plant also manufactures 7 other chemicals and products.
B-18
-------
HOFFMAN-LA ROCHE, INC.
MUSKEGON, MICHIGAN 49442
Dyclom'ne hydrochloride
Thiphenamic hydrochloride
*Plant also manufactures 21 other chemicals.
HUMMEL CHEMICAL COMPANY
SOUTH PLAINFIELD, NEW JERSEY 07080
Methapyrilene
Methapyrilene fumarate
Methapyrilene hydrochloride
*Plant also manufactures 67 other chemicals and products.
ICI AMERICAS, INC.
NEWARK, DELAWARE 19711
Isosorbide dinitrate
*Plant also manufactures 1 other product,
ICI AMERICAS, INC.
PASADENA, CALIFORNIA 91109
Isosorbide dinitrate
*Plant also manufactures 7 other products.
INOLEX CORP.
PARK FOREST SOUTH, ILLINOIS 60466
Ammonium heparin
Bile acids, oxidized
Bile salts
Dehydrocholic acid
Epinephrine (levo)
Liver concentrate
Liver, desiccated
Pepsin
Sodium heparin
Trysin
*Plant also manufactures 7 other chemicals and products.
B-19
-------
INTERNATIONAL MINERALS AND CHEMICAL CORP.
TERRA HAUTE, INDIANA 47808
Bacitracin
Bacitracin ( no timed icinal)
Bacitracin, zinc
Bacitracin, zinc (nonmedicinal)
Choline chloride
Hexetidine
Tromethami ne
INTERNATIONAL RECTIFIER CORP.
RACHELLE LABORATORIES
LONG BEACH, CALIFORNIA 90801
Chloramphenicol
Chlordiazepoxide
Chiortetracycli ne
Doxycycline
Oxytetracycline hydrochloride
Tetracycl i ne hydrochl on' de
KOPPERS COMPANY, INC.
PETROLIA, PENNSYLVANIA' 16050
Resorcinol
*Plant also manufactures 8 other chemicals and products.
ELI LILLY AND COMPANY
CAROLINA, PUERTO RICO 00630
Tobramtcin sulfate
, ELI LILLY AND COMPANY
LAFAYETTE, INDIANA 47902
Acetohexamide
N-Carbamoylarsanilic acid
Cephalexin monohydrate
Cephaloridine
Cephalothin
Cephalothin, sodium
Cyclopentamine hydrochloride
Dioxyline phosphate
Erythromycin
Ethi namate
Ethomoxane hydrochloride
B-20
-------
ELI LILLY AND COMPANY (CONTINUED)
nJ' 5"d1hydr0"4"OXO"1'3"d1oxo1o(4'5"9)cinno^ne-3-carboxyl1c acid
dl-4-(2-E3-(p-hydroxyphenl)-l-methylpropyi:amino)ethylcathechol, hydrochloride
Hygromycin B
Insulin
Methadone hydrochloride
Methapyrilene hydroxybenzoylbenzoate
Methimazole
Methohexital, sodium
Nortripthyline
Papaverine hydrochloride
Penicillin G, potassium
Penicillin G, procaine
Penicillin G, procaine (nonmedicinal)
Phenoxymethyl penicillin
Phenoxymethyl penicillin, potassium
2-(3-phenoxypheny) propionic acid Gallium salt dihydrate
Piperocaine hydrochloride
Pyrrobutamine hydrobromide
Pyrrobutamine phosphate
Tylosin
Vancomycin
Vinblastine sulfate
Vincristine sulfate
*Plant also manufactures 46 other chemicals.
LONZA, INC.
MAPLETON, ILLINOIS 61547
Niacin
Niacinamide
*Plant also manufactures 184 other chemicals and products.
MALLINCKRODT, INC.
ST. LOUIS, MISSOURI 63147
Bismuth subgallate
Bismuth subsalicylate
Calcium gluconate
Ethyl ether (medicinal)
lodoform
Resorcinol
Zinc phenolsulfonate
lothalamic acid
Acetaminophen
"Amy! nitrate
B-21
-------
MALLINCKRODT, INC. (CONTINUED)
Codeine
Codeine phosphate
Codeine sulfate
Dihydrocodeine bitartrate
Diphenoxylate hydrochloride
Ferric hydrophosphate
Ferrous fumarate
Hydrocodone bitartrate
Magnesium citrate
Morphone sulfate
Noscapine
Oxycodone hydrochloride
Oxycodone terephthalate
Phenobarbital
Thebaine
Thymol iodide
*Plant also manufactures 133 other chemicals and products.
MERCK & CO., INC.
ALBANY, GEORGIA 31701
Chlorothiazide
Hydrochorothiazide
Methyldopa
Probencid
Sulfanil amide
"'Plant manufactures 2 other chemicals and products.
MERCK & CO., INC.
DANVILLE, PENNSYLVANIA 17821
Dexamethasone
Dexamethasone phosphate
Ethopabate
Hydrocortisone acetate
Hydrocortisone phosphate
Methyldopa
Penicillin G, procaine (nonmedical)
Prednisolone-tert-butylacetate
Prednisolone phosphate
Riboflavin
Ronidazone
Sulindac
B-22
-------
MERCK & CO., INC.
ELKTON, VIRGINIA 22827
Amproll urn
Carbidoda
Cefoxitin
Cyanocobalamin
Nicarbazin
Sulfaquinoxaline
*Plant also manufactures 3 other products.
MERCK & CO., INC.
RAHWAY, NEW JERSEY 07065
Amitriphyline hydrochloride
Anileridine hydrochloride
Apomorphine hydrochloride
Bethanechol chloride
Bismuth formic iodide
Cambendazole
Carbachol
Cocaine
Codeine
Cyclobenzapri ne
Cyproheptadine hydrocholoride
Dichlorphenamide
Ethacrynic acid
Ethylmorphine hydrochloride
Gold sodium thiomalate
Hexaylcaine hydrochloride
Hexylresorcinol
Hydrocodone bitartrate
Indomethacin
Mecamylamine
Metaraminol bitartrate
Methacholine chloride
Methyldopate hydrochloride
Metyrosine
Monochloracetone
Morphine
Nalorphine hydrochloride
Noscapine
Oxycodone hydrochloride
p-Pentoxyphenol
Phthalysulfathiazole
Phytonadione
Protriptyline hydrochloride
Sulfabromomethazine, sodium
B-23
-------
MERCK & CO. , INC.
Thiabendazole
Timocol maleate
*Plant also manufactures 4 other chemicals and products.
MERCK & CO. , INC.
HAWTHORNE, NEW JERSEY 07507
Chioromercuriphenol
Mercuric sal icylate
Oxyquinoline
Oxyquinoline, citrate
Oxyquinoline, sulfate
*Plant also manufactures 13 other chemicals and products.
Methyldopa
MERCK & CO., INC.
BARCELONETA, PUERTO RICO 00617
MILES LABORATORIES, INC.
CLIFTON, NEW JERSEY
Pepsin
*Plant also manufactures 14 other chemicals.
Sodium heparin
MINNESOTA MINING AND MANUFACTURING CO.
RIKER LABORATORIES
CORDOVA, ILLINOIS 61242
MINNESOTA MINING AND MANUFACTURING CO.
RIKER LABORATORIES
NORTHRIDGE, CALIFORNIA 91324
Alkaveruir
Alseroxylone
Ammonium heparin
Calcium heparin
Chlophedianol hydrochloride
Deanol p-acetamidobenzoate
Lithium heparin
B-24
-------
MINNESOTA MINING AND MANUFACTURING CO. (CONTINUED)
Methenamine hippurate
Orphenadrine citrate
Orphenadrine hydrochloride
Sodium hepan'n
MONSANTO COMPANY
LULING, LOUISIANA 70070
Acetaminophen
*Plant also manufactures 7 other chemicals and products.
MONSANTO COMPANY
NITRO, WEST VIRGINIA 25143
Methionine, hydroxy analogue, calcium salt
*Plant also manufactures 20 other chemicals and products.
MONSANTO COMPANY
ST. LOUIS, MISSOURI 63177
Aspirin
L-dopa
Methapyrilene fumarate
Methapyrilene hydrochloride
Phenacetin
Salicylic acid
*Plant also manufactures 20 other chemicals and products.
MORTON-NORWICH PRODUCTS, INC.
NORWICH, NEW YORK 13815
Aspirin
Furazolidone
Nifuralidone
Nihydrazone
Nitrofurantoin
Nitrofurazone
*Plant also manufactures 6 other chemicals.
B-25
-------
Nitrofurantoin
MORTON-NORWICH PRODUCTS, INC.
MANATI, PUERTO RICO 00701
NAPP CHEMICALS, INC.
LODI, NEW JERSEY 07644
Aminobenzoic acid
Betaine hydrochloride
Bisacodyl
Calcium glutamate
Calcium succinate
Diiodohydroxyquin
Ethyl p-aminobenzoate
Glutamic acid hydrochloride
lodochlorhydroxyqui n
Lidocaine
Methionine
Orphenadrine citrate
Oxyquinoline
Oxyquinoline benzoate
Oxyquinoline sulfate
Phenylto!examine dihydrogen citrate
Phthalylsulfacetami de
Potassium glutamate
Propoxyphen hydrochloride
Resorcinol
Sodium caprylate
Sulfacetamide
Sulfacetamide, sodium
Sulfadiazine
Sulfaguanidine
Sulfamerazine
Sulfamethazine
Sulfanilamide
Sulfapyridine
Sulfathiazole
Sulfathiazole, sodium
*Plant also manufactures 10 other chemicals.
NEPERA CHEMICAL CO.
HARRIMAN, NEW YORK
INC.
10926
Methenamine mandelate
Niacin
Niacinamide
B-26
-------
NEPERA CHEMICAL CO., INC.
Phenazopyridine hydrochloride
Phenylpropanolamine hydrochloride
Thonzylamine hydrochloride
*Plant also manufactures 10 other chemicals.
N. L. INDUSTRIES, INC.
BAYONNE, NEW JERSEY 07002
Zinc undecylenate
*Plant also manufactures 36 other chemicals and products.
NORDA, INC.
NEWARK, NEW JERSEY 07114
Chlorothymoc
*Plant also manufactures 46 other chemicals and products.
NORTH AMERICAN PHILIPS CORP.
KANSAS CITY, KANSAS 66110
Choline chloride
*Plant also manufactures 8 other chemicals and products.
NORTH AMERICAN PHILIPS CORP.
WAUKEGAN, ILLINOIS 60085
Calcium pantothenate (racemic) calcium chloride complex
ORGANICS, INC.
CHICAGO, ILLINOIS 60625
Adrenocorticotropin
Estrogenic substances, conjugated
Hormones, steroid type
Natural estrogenic substance
B-27
-------
OSCAR MAYER & CO.
MADISON, WISCONSIN 53701
Pepsin
Sodium heparin
*Plant also manufactures 1 other chemical.
PENNWALT CORPORATION
BUFFALO, NEW YORK 14240
Calcium undecylenate
Zinc undecylenate
*Plant also manufactures 7 other chemicals.
PFANSTIEHL LABORATOTIES, INC.
WAUKEGAN, ILLINOIS 60085
L-Cysteine hydrochloride
*Plant also manufactures 73 other chemicals and products.
PFIZER, INC.
BOOKLYN, NEW YORK 11206
Bacitracin
Calcium gluconate
Copper gluconate
Dihydrostreptomycin
Ferrous gluconate
Hydrocortisone
Magnesium gluconate
Oleandomycin
Potassium gluconate
Viomycin
PFIZER, INC.
GROTON, CONNECTICUT 06340
Ascorbic acid
Benzthiazide
Caffeine, synthetic
Carbetapentane citrate
Doxyeyeline
Hydrocortisone
Hydroxyzine hydrochloride
Hydroxyzine pamoate
B-28
-------
PFIZER, INC. (CONTINUED)
Methacycline
Neomycin
Neomycin sulfate (nonmedicinal)
Oleandomycin
Oxyphencycl inline hydrochloride
Penicillin G
Penicillin G, potassium
Penicillin G, procaine
Penicillin G, sodium
Penicillin 0, sodium
Phenethicillin, potassium
Phenoxymethyl penicillin
Polythiazide
Procaine hydrochloride
Pyranthel pamoate
Pyranthel tartrate
Streptomycin
Streptomycin (nonmedical)
Tetracycline
Tetrahydrozoline hydrochloride
Troleandomycin
Viomycin
Vitamin A acetate
Vitamin A alcohol
Vitamin A palmitate
*Plant also manufactures 21 other chemicals and products.
PFIZER, INC.
TERRE HAUTE, INDIANA 47808
Cyanocobalamin
Oxytetracycline (nonmedicinal),
Streptomycin (nonmedicinal)
^Plant also manufactures 3 other chemicals.
PHARMACHEM CORP.
BETHLEHEM, PENNSYLVANIA 18018
Dextran
*Plant also manufactures 4 other chemicals and products.
B-29
-------
POLYCHEMICAL LABORATORIES, INC.
BRONX, NEW YORK 10474
Acetylcholine chloride
Calcium levulinate
Calcium phytate
N-Carbamoylarsanilic acid
Chlorpheniramine maleate
Danthron
Diiodohydroxyquin
Diphenylhydantoin, sodium
Glycobiarsol
lodochlorhydroxyquin
Methenamine mandelate
Naphazoline hydrochloride
Oxyquineline hydrochloride
Oxyquinoline sulfate
Phtahlylsulfacetamide
Piperazine adipate
Piperazine citrate
Piperazine tartrate
Propy1thi ouraci1
Pyrilamine maleate
Sodium arsanilate
Thimerosal
*Plant also manufactures 10 other chemicals.
REILLY TAR & CHEMICAL CORP.
INDIANAPOLIS, INDIANA 46204
Niacin
Niacinamide
*Plant also manufactures 90 other chemicals and products.
REVLON, INC.
KANKAKEE, ILLINOIS 60901
Adrenocorticotropin
Bile extracts
Chymotrypsin
Insulin
Oxytoci n
Trypsin
*Plant also manufactures 15 other products.
B-30
-------
RHONE-POULENC, INC.
NEW BRUNSWICK, NEW JERSEY 08901
Dimetridazole
Glycol monosalicylate
Metronidazole
*Plant also manufactures 11 other chemicals and products.
RICHARDSON-MERRELL, INC.
PHILLIPSBURG, NEW JERSEY 08865
Azacyclonol hydrochloride
Bismuth subgallate
Chiorotrianisene
Dicyclomine hydrochloride
Diethylpropion hydrochloride
Doxy!amine succinate
*Plant also manufactures 117 other chemicals.
R.S.A. CORP.
ARDSLEY, NEW YORK 10502
Acetylcholine bromide
Acetylcholine chloride
Acetylcholine iodide
Acetyl-p-methylcholine bromide
Acetyl-p-methylcholine chloride
Aspirin, calcium salt
Butyl aminobenzoate
Dibucaine hydrochloride
Diiodohydroxyquin
Guaiacol sal icylate
Hexamethonium chloride
Hexamethonium iodide
Hexylresorcino.l
4-Hydroxynicotinic acid
Isobuty1e-p-aminobenzoate
Methacholine chloride
Methenamine mandelate
Phenylbutazone, sodium salt
Propantheline bromide
Propyl aminobenzoate
Sal icy! alcohol
Tetracaine
Tetracaine hydrochloride
Tetraethylammonium chloride
*Plant also manufactures 297 other chemicals.
B-31
-------
RUETGERS-NEASE CHEMICAL COMPANY, INC.
STATE COLLEGE, PENNSYLVANIA 16801
Chiorami nophenami de
*Plant also manufactures 18 other chemicals.
SALSBURY LABORATORIES
CHARLES CITY, IOWA 50616
Ammonium phenolsulfonate
Sali cylazos ulfapyri di ne
Sodium phenolsulfonate
Sulfanil amide
Sulfapyridine .
Zinc phenolsulfonate
*Plant also manufactures 16 other chemicals.
SCM CORPORATION
GAINESVILLE, FLORDIA 32601
Acepromazine
Chiordiazepoxide
Chlorpromazine hydrochloride
5-Fluorouracil
Halothane
Promazine hydrochloride
*Plant also manufactures 60 other chemicals and products.
G. D. SEARLE & CO.
SKOKIE, ILLINOIS 60075
Aminophylcine
Dimenhydrinate
Estradiol
Ethisterone
Methyl testosterone
Spironolactone
Testosterone
Testosterone and esters
SHELL CHEMICAL COMPANY
DENVER, COLORADO 80201
2,2-Dichlorovinyl-0,0-dimethyl phosphate
*Plant also manufactures 5 other chemicals.
B-32
-------
SMITHKLINE CORP.
PHILADELPHIA, PENNSYLVANIA 19101
Amphetamine sulfate (racemic)
Caramiphen edisylate
Chlorpheniramine maleate
Chlorpromazine, base
Chlorpromazine hydrochloride
Dextroamphetamine sulfate
Hydroxyamphetamine hydrobromide
Isopropamide Iodide
Prochlorperazine, base
Prochlorperazine edisylate
Prochlorperazine maleate
Propy1hexedri ne
Triamterene
Trifluoperazine, base
Trifluoperazine hydrochloride
Trimeprazine tartrate
*Plant also manufactures 8 other chemicals.
SMITHKLINE CORP.
SWEDELAND, PENNSYLVANIA 19479
Cefazolin
Cephradine
SMITHKLINE CORP.
GUYAMA, PUERTO RICO
Cimetidine
Cimetidine hydrochloride
SOUTHLAND CORP.
GREAT MEADOWS, NEW JERSEY
5-Chloro-8-Quinolinol
Diiodohydroxyquin
Oxyquinoline
Oxyquinoline benzoate
Oxyquinoline citrate
Oxyquinoline sulfate
Phenylpropanolamine hydrochloride
6-Methoxytetralone-1
5-nitroisophthalic acid
M-Ni tro-p-phenylenediami ne
4-Nitro-o-phenylenediamine
*Plant also manufactures 32 other chemicals.
B-33
07838
-------
SQUIBB CORP.
NEW BRUNSWICK, NEW JERSEY
08903
Amphotericln B
Bendrof1umethi azi de
Diatrizoate, meglumine
Diatrizoate, sodium
Diatrizoic acid
FTumethiazide
Fluphenazine hydrochloride
Insulin
lodipamide, meglumine
lodipamide, sodium
Neomycin
Nystatin
Nystatin (nonmedicinal)
Penicillin G, potassium
Penicillin G
Procainamide
Proparacaine
Sincalide
Thirostrepton
Tri f1upromazi ne
procaine (nonmedicinal)
hydrochloride
hydrochloride
*Plant also manufactures 2 other chemicals.
SQUIBB CORP.
HUMACAO, PUERTO RICO
Cephradine
Halcinonide
Triamcinolone
Triamcinolone acetonide
Triamcinolone diacetate
Amphotericin B
Nystati n
Amoxicillin
Ampicillin
Ampicillin, trihydrate
Dihydroampicill in
A. E. STALEY MFG. CO.
DECATUR, ILLINOIS
Ami no acid mixtures
Inositol
Lecithin
B-34
-------
STANSBURY CHEMICAL CO. , INC.
SEATTLE, WASHINGTON
Ephinephrine
STERLING DRUG, INC.
CINCINNATI, OHIO
Benzalkonium chloride
Gentian violet
Nalidixic acid
Salicylic acid
*Plant also manufactures 34 other chemicals.
STERLING DRUG, INC.
RENSSELAER, NEW YORK
Acetarsone
Aminacrine
Aminacrine hydrochloride
Arterenol hydrochloride (racemic)
Arterenone
Cetalkonium chloride
Cinnamylephedrine hydrochloride
Danthron
Diatrizoate, sodium
Epinephrine bitartrate (levo)
Ethacridine lactate
Isoproterenol hydrochloride
Levarterenol bitartrate, monohydrate
Lidocaine
Lidocaine hydrochloride
Mafenide hydrochloride
Mafenide hydrochloride
Meperidine hydrochloride
Mepivacaine hydrochloride
dl-Metanephrine hydrochloride
Metaraminol bitartrate
Nordefrin hydrochloride
Norepinephrine
Norepinephrine bitartrate
dl-Normetanephrine hydrochloride
Pepsin
Phenacaine hydrochloride
Phenylalanine
Phenylephrine
Phenylephrine hydrochloride
Primaquine phosphate
Quinacrine hydrochloride
B-35
-------
STERLING DRUG, INC. (CONTINUED)
Succinylcholine chloride
Tetracai ne
Tetracaine hydrochloride
Trihexyphenidyl hydrochloride
L-Tryptophan
*Plant also manufactures 17 other chemicals.
SYNTEX CORPORATION
SPRINGFIELD, MISSOURI
Allantoin
Betaine base
Calcium pantothenate (dextro)
Calcium pantothenate (racemic)
*Plant also manufactures 1 other chemical.
SYNTEX CORPORATION
VERONA, MISSOURI
B-Alanine
Bethine hydrochloride
Calcium pantothenate (racemic) calcium chloride complex
Choline bitartrate
Choline chloride
Choline dihydrogen citrate
Ethylenedi ami ne di hydroi odi de
Panto!actone
*Plant also manufactures 3 other chemicals.
TENNECO CHEMICALS, INC.
GARFIELD, NEW JERSEY
Phenyl sal icylate
Potassium guaicolsulfonate
Potassium sal icy!ate
Salicylic acid
Salicylsalicylic acid
Sodium salicylate
*P!ant also manufactures 16 other chemicals.
B-36
-------
TYLER CORPORATION
TAMAQUA, PENNSYLVANIA
Glyceryl trinitrate
Isosorbide dinitrate
Mannitol hexanitrate
Pentaerythritol tetranltrate
*Plant also manufactures 7 other chemicals.
UNION CARBIDE CORPORATION
TEXAS CITY, TEXAS
Piperaine, base
Piperazine, derivatives
*PTant also manufactures 43 other chemicals.
THE UPJOHN COMPANY
KALAMAZOO, MICHIGAN
Chlorphenesin
Colestidol
Cortisone
Cortisone acetate
Cytarabine
Cytarabine hydrochloride
Diflorasone diacetate
Diphenadione
Ephedrine hydrochloride
Ephedrine sulfate
Erythromycin
Erythromycin stearate
Estradiol cypionate
Ethisterone
Fluorocortisone acetate
Flurometholone
9-of-Fluroprednisolone acetate
Fluoxymesterone
Fluprednisolone
Hydrocrotisone
Hydrocortisone acetate
Hydrocortisone cypionate
Hydrocrotisone hemisuccinate
Hydrocortisone sodium succinate
lla-Hydroxypregn-4-ene-3,20-dione
17a-Hydroxyprogesterone
Hydroxyprogesterone caproate
Lincomycin hydrochloride
Medroxyprogesterone acetate
B-37
-------
THE UPJOHN COMPANY (CONTINUED)
Melengestrol acetate
Sot-Methyl predni sol one
Methylprednisol one acetate
Methylprednisol one sodium succinate
Methyl testosterone
Mibolerone
Neomycin sulfate
Novobiocin
Novobiocin calcium
Novobiocin sodium
Prednisol one
Prednisol one acetate
Prednisone
Progesterone
Prostaglandins
Spectinomycin dihydrochloride
Spectinornycin sulfate
Tetracyclone hydrochloride
Tolazamide
Tolbutamide
*Plant also manufactures 15 other organic chemicals.
THE UPJOHN COMPANY
ARECIBO, PUERTO RICO
Clindamycin
Clindamycin palmitate
Clindamycin phospate
Ibuprofen
Lincomycin
VITAMINS, INC.
CHICAGO, ILLINOIS
7-Dehydrocholesterol
Vitamin D2
Vitamin D3
VITAMINS, INC.
MICHIGAN CITY, INDIANA
Ergosterol
*Plant also manufactures 4 other organic chemicals.
B-38
-------
WARNER-LAMBERT COMPANY
HOLLAND, MICHIGAN
Ami tn'pty line
Amodiaquin
Amodiaquin hydrochloride
Bisacodyl
Bromodiphenhydramine hydrochloride
Carbromal
Chiordiazepoxide
Diphenhydramine hydrochloride
Diphenylhydantoin
Diphenylhydantoin, sodium
Ethosuximide
Ethyl-p-ami nobenzoate
Ketamine hydrochloride
Meclofenamic acid
Mefenamic acid
Methsuximide
Oxolinic acid
Oxytocin
Phensuximide
Pheny1propanolamine hydrochloride
Prazepam
Procainamide hydrochloride
Procaine hydrochloride
Propylhexedrine
Sal icy!salicylic acid
Thiamycal, sodium
Vasopressin
*Plant also manufactures 18 other chemicals.
WEST CHEMICAL PRODUCTS, INC.
EIGHTY FOUR, PENNSYLVANIA
Phenbthiazine
*Plant also manufactures 3 other chemicals.
WEST CHEMICAL PRODUCTS, INC.
HAMILTON, NEW YORK
Dry cow injectable antibiotics
Lactating cow injectable antibiotics
B-39
-------
WEST CHEMICAL PRODUCTS, INC.
KANSAS CITY, MISSOURI
Ethylenedianrine dihydroiodide
*Plant also manufactures 2 other organic chemicals.
B-40
-------
TECHNICAL REPORT DATA
(Please read Instructions en the reverse before completing)
1. REF
-80-016
3. RECIPIENT'S ACCESSION NO.
4. TITLE AND SUBTITLE
Enforceability Aspects for RACT for the Chemical
Synthesis Pharmaceutical Industry
5. REPORT DATE
January 1QR1
6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
T. Briggs, C. Harvey, J. McClure,
R. Pollard-Cavalli
8. PERFORMING ORGANIZATION REPORT NO.
PN 3570-3-K
9 PERFORMING ORGANIZATION NAME AND ADDRESS
PEDCo Environmental, Inc.
11499 Chester Road
Cincinnati, Ohio 45246
10. PROGRAM ELEMENT NO.
11. CONTRACT/GRANT NO.
68-01-4147
Task No. 128
12. SPONSORING AGENCY NAME AND ADDRESS
U.S. Environmental Protection Agency
Division of Stationary Source Enforcement
Washington, D.C. 20460
13. TYPE OF REPORT AND PERIOD COVERED
Final "
14. SPONSORING AGENCY CODE
5. SUPPLEMENTARY NOTES
Project Officer: John R. Busik
Task Manager: Robert L. King
6. ABSTRAC1
Reasonably available control technology (RACT) requirements apply to
pharmaceutical manufacturing plants using synthesis processes that emit more
than Ib pounds per day of volatile organic compounds (VOC) located in photo-
chemical oxidant nonattainment areas. There are 140 operating pharmaceutical
plants that use chemical synthesis processes in the 10 U.S. Environmental Pro-
tection Agency regions; 116 of these are located in. nonattainment areas. A
current survey of the operating synthetic pharmaceutical manufacturing plants
is necessary for the enforcement of RACT and for long-range planning of EPA
regional, and local programs and resources. This report provides an inventory
of the operating synthetic pharmaceutical manufacturing plants, an industry
tnTmndP^T?^-"' V6^
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