corp overview

Pharmaceutical Grade Solvents

for Global Requirements

Direct Account Presentation

Pharma Solvents for Global Requirements

Producer and Manufacturer

HIGH PURITY ETHANOL For Pharma, Medical & Critical Industrial Applications

PHARMACEUTICAL GRADE SOLVENTS

That exceed Global requirements

STERILE SOLVENTS & CUSTOM BLENDS

In Production Quantities for Demanding Markets

Our Purpose

Our purpose is to provide pharmaceutical grade process solvents in production

quantities that enable our clients to stay one step ahead of ever-increasing

global requirements.

Pharmco-Aaper is an FDA registered facility operating under all applicable

current good manufacturing practices (cGMP.)

Our references include an impressive array of U.S. and international companies!

Note: all pictures contained in this presentation are actual photos of our facilities and employees!

Sample List of Clients

PHARMACEUTICAL:

3M, Abbott, Amgen, Anchen, Astra-Zeneca, Aventis, Baxter, Bayer, Becton Dickinson, Biogen, Boehringer-Ingleheim,

Bristol Myers Squibb (BMS), Catalent, Cambrex Bioscience, Catalytica Pharmaceutical, Celltrion, Cenacor, Colorcon,

Cott, Covidien, EISAI, Eli Lilly, Genzyme,

Glaxo Smith Kline, Hoffmann La Roche, Hospira, Imclone, Johnson & Johnson Companies,

Midimmune, Merck, Novartis, Ortho-McNeil, Ortho-Pharma, Ortho-Biotech, Pfizer,

Polysciences, Precision Pharmaceutical, Purdue Pharma, Roche, Sanofi-Pastuer,

Sandoz, Schering Plough, Stiefel Labs, Sun Pharma, TEVA, Warner-Lambert, Wyeth.

Flavor & Fragrance:

Adams Extracts, Alan Flavors, Citroil, Firmenich, Fruterom, Givaudan, IFF, Kerry-Matertaste,

OSF Quest, Robertet, Sensient, Sovereign Flavors, Symrise, T.Hasegawa, Virginia Dare.

Specialty Chemical and Critical Industrial:

Acros, American Distilling, BASF, Cytec, Dupont, Honeywell, ISP, Monsanto, Noramco, Ophthalmic Innovations, P&G,

Phillip Morris, Sigma-Adrich, Stepan, Unilever.

Government, Educational and Medical Institutions:

CDC, DEA, DEP, EPA, FDA, Harvard, Institute for Genomic Research, Memorial Sloan Kettering,

MIT, NASA, National Institute of Health (NIH), New York University, UCLA – Medical, NYU,

Princeton, Scripps Research Institute, UMDNJ, Yale.


Our Parent Company

Our parent company (GFE) is the largest producer of

Ethanol in Canada.

GFE produces over 30 million gallons (114 million

liters) per year of high purity ethanol at our plant in

Chatham, Ontario, Canada.


Spotlight on Chatham

Our Chatham plant is our premier Ethanol facility producing the

highest quality analytical and pharmaceutical grade ethanol in the world.

NOTES:

1. Ability to expand beyond our capacity to meet global requirements.

2. Full testing of each railcar prior to shipment

Dedicated fleet of railcars

3. ISSO9001:2008 compliant.

4. FDA compliant.

5. Zero waste facility and Negative carbon footprint.


Chatham’s Unique Distillation System

Our Eight column distillation system gives us the ability to produce Ethanol to these quality levels.


Ethanol Products

1. Highest pharmaceutical and analytical grade quality in the world.

2. Comprehensive line of pure and denatured ethanol products including custom cuts,

blends and formulas.

3. Multi-compendial certified finished products – each lot! Minimum specs: USP/ACS

and Kosher.

Notes:

1. Complete ownership and control of quality

2. Full testing upon receipt and full compendial testing

for each packaged lot.

3. 0.22 micron filtered.

4. Produced from a renewable resource: corn.

5. Dedicated Railcars for transportation from producer to packaging site.


Pharmaceutical Grade Solvents

1. Full monograph testing of all raw material prior to receipt, during filling and final

product.

2. Custom blends and specifications.

3. Package options from pints to Iso-tainers and tank trucks.


Sterile Solvents and Custom Blends

1. Ethanol and related solvents from small package

to production quantities.

2. Custom specifications and blends.

3. Endotoxin free products / Gamma Irradiation for sterility.

4. Validation programs upon request.

5. Full compendial and sterility testing on each packaged lot.


Quality Products: Added Value to benefit you

1. Multi-compendial certification.

2. Custom specifications, blends and sterile products.

3. The highest quality ethanol in the world.

4. A comprehensive range of pure and denatured

ethanol products.

5. Fully tested finished product.


Quality Process: Resources to empower you

1. Dedicated manufacturing facilities offering security of supply and total control of

quality, from raw material to finished product.

2. Fully staffed on-site quality control labs at each facility and plant.

3. FDA registration for drug and medical device establishment / Organic, Kosher,

HACCP & cGMP operation: Total quality system under ISO registration.

Notes:

1. Rigorous internal auditing.

2. Robust change control systems and continuous

process improvement.

3. Separate Quality Control and Quality Assurance departments.

4. Finished goods warehouses throughout the U.S. and the world.

5. Environmentally compliant, zero-waste facilities.

6. Strategically located near the port of NY (U.S.) for ease of export.


Quality People: Ready to Assist you

Technical Support

1. Ethanol product selection; pure and denatured.

2. Custom solvent development and validation requirements.

3. High purity solvent selection.

4. Issuance of product samples and literature.

5. Assistance with regulatory compliance.


Business Continuity

Brookfield, Connecticut

50,000 square foot facility

Shelbyville, Kentucky


Brampton, Ontario


Our three manufacturing and packing locations are integrated to support each other in the event of

any business interruption.


Full Range of Production Capabilities

1. Stainless Steel Batching Tanks.

2. Class 10,000 Clean Room & cGMP White Room.

3. High speed filling lines.

4. Dedicated storage tanks.

5. Custom label printing department.

6. 0.22 micron filtering systems.

7. Packaging capabilities from pints to iso-tainers.

1.25 Million Gallons of Storage


Clean and White Rooms

We are the only ethanol producer or manufacturer in the Western Hemisphere that is FDA and ISO

registered with an on-site Class 10,000 Clean Room and a cGMP / Kosher / HACCP compliant White

Room.

Notes:

1. FDA registration for drug and medical device establishment.

2. Class 10,000 Clean Room and White Room facilities.

3. Organic, Kosher, HACCP & cGMP operations.

4. Capacity to expand.

5. Capacity for custom blends and products.

6. Validated room and validated process.

7. Operates as an integrated part of our total quality system.

8. Small package and drum capabilities.

9. Gamma Irradiated and Endotoxin Free Products.


QUALITY CONTROL LAB

1. Our on-site lab is equipped with state of the art instrumentation and adequately staffed

2. We analyze all raw material well beyond compendial requirements to insure our

understanding of the quality of our finished products.

3. We offer certificates of analysis on raw material as well as finished goods.


Spotlight on Improvement – ICP-MS Unit

1. New USP standards in 2013.

2. Metals analysis for select solvents.

ICP-MS INSTRUMENT


LABEL ROOM

1. In house printing capabilities.

2. Custom labeling.

3. Fully integrated and under the supervision of our quality system.


Multiple Packaging Options

Our extensive packaging options allow for a finished product scale up range from pints to tank trucks

and iso-tainers.

Pints: Poly and Glass

500ml: Glass and Poly

1 Liter: Glass and Poly

Gallons: Poly

4 x 4 Liter: Glass

2.5 Liter: Glass and Poly

5 Gallon Shelf Sitters, cubes, poly & metal

30 Gallon Drum: Poly

55 Gallon new Metal lined-Drum

55 Gallon new Poly Drum

55 Gallon Drum: UV protected

Tanks: SS Trucks and Iso-tainers

Other options: please inquire


Multi-Compendial Product Overview (EP/BP/JP/USP/ACS/FCC…)

1. Ethanol (Pure and Denatured), Kosher, Organic, KFP, other

2. Ethanol Blends and cuts

3. Acetone

4. Benzyl Alcohol

5. Dichloromethane

6. DEP

7. Ethyl Acetate

8. Ethyl Ether

9. Glycerin

10. IPA (99%, 70% and various cuts)

11. Methanol

12. n-Propyl Alcohol

13. Propylene Glycol (PG)

14. WATER: USP, EP, Distilled, WFI

15. Custom Solvent Blends

16. Sterile Solvents

Please Inquire for other solvents!

Other common USP & ACS Grade Solvents used in API

production handled through the same dedicated, regulated

systems:

1. Acetonitrile

2. n-Butyl Alcohol

3. Chloroform

4. DMF

5. Ethylene Glycol

6. Heptane

7. Hexane

8. MEK

9. MIBK

10. MTBE

11. Pentane

12. Petroleum Ether

13. Tetrahydrofuran (THF)

14. Toluene

15. TMP (Trimethyl Pentane, 2,2,4)

corp overview

Documents

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highest quality ethanol

pharmaceutical grade

related solvents

quality process

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analytical grade quality

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