BERGAMOEXPERTS TAKING CARE

Corden Pharma Bergamo S.p.A. Via Bergamo, 121

24047 Treviglio (BG)Italy

Phone +39 0363 31401Fax +39 0363 45985

www.cordenpharma.com/contact-us/

www.cordenpharma.com

CORDENPHARMA

CORDENPHARMA BERGAMOCordenPharma Bergamo, located in Treviglio – Bergamo, Italy, brings over 50 years of experience in API manufacturing. Previously known as Farchemia, our core business is the manufacturing of pharmaceutical and veterinary intermediates and bulk products by chemical synthesis. CordenPharma Bergamo also

develops and supplies a wide range of Generic APIs (see our product lists) and offers custom synthesis capabilities. Customers benefit from our wide array of integrated services including process research and development, optimization, and scale-up facilities to support both validation and commercial launch. Our extensive experience

is supported by advanced multipurpose manufacturing facilities and strengthened by a regulatory culture that has achieved 20 years of successful FDA inspections. CordenPharma Bergamo has developed the expertise and resources to internally manage all Quality & Compliance and Regulatory Affairs activities.

Our History• 1962 Foundation of Farchemia

by a private owner • 1979 First FDA inspection• 1989 Acquired by

Tessenderlo Group• 2011 Italian MoH Veterinary

approval• 2012 Acquired by ICIG

to join CordenPharma’s network of facilities

• 2016 Latest FDA & EMA inspections

• 2016 Name changed to Corden Pharma Bergamo S.p.A

APIs & Custom Manufacturing

Full-Service CMO

US Compliance Worldwide• EMA • FDA• PMDA• ISO 9001: 2008• OHSAS 18001: 2007

CORE CAPABILITIES

WHAT WE DO 28 DMFs Filed & 6 CEPs Granted

>20 Patents Granted

With more than 50 years of experience in manufacturing Active Pharmaceuticals Ingredients, CordenPharma Bergamo adds to the CordenPharma network consolidated know-how in a wide range of typical chemical reactions. The multi-purpose plant has been successfully inspected by the FDA since 1979, and offers about 600 m3 of capacity in both stainless steel and glass-lined reactors. The site is regularly inspected by more than 200 customers, including all of the Top 10 World Pharma Companies. CordenPharma Bergamo provides customers analytical and regulatory services in compliance with major worldwide Agencies.

In our two plants located on the same premises,CordenPharma Bergamo has the ability and equipment to utilize a large variety of chemistries for Intermediates and API production including:• Acylation• Alcoholysis• Alcoxylation• Alkylation• Amidation• Amination• Bromination• Carboxymethylation• Dehydrogenation• Diazotisation• Ethoxylation• Friedel-Crafts• Hydrogenation• Hydroxylation• Mannich Reaction

• Optical Resolution• Oxidation• Sandmeyer reaction• Vilsmeier reaction

Reaction, pressure and vacuum conditions range from:• Reaction: -20 °C up to +290 °C• Pressure: up to 15 bar• Vacuum: as low as 1 mbar

We have consolidated expertise in working with:• Aromatic Amines• Ammonia• Hydrazine Hydrate• Ethylene Oxide• Thionyl Chloride• Phosphorus Oxychloride• Dimethyl Sulphate• Propylene oxide

Our proven ability tohandle multi-stepsynthesis for complexprocesses makes usyour ideal partnerfor developing andmanufacturing yourproducts.

EQUIPMENT DETAILS PLANT A • Electrical power installed: 200 kW• Supplied with industrial, potable and purified water• Sewage and drainage system with connecting

interceptors which discharge into the main drain• 26 Reaction vessels with a capacity ranging from 1,500 to 28,000 in AISI 316 or glass-lined

• 10 Centrifuges in AISI 316 or HALAR – AISI• ID11 – B1/A Centrifuge and dryer in closed loop with direct loading system

PLANT B • Electrical power installed: 300 kW• Supplied with industrial, potable and purified water• Sewage and drainage system with connecting interceptors which discharge into the main drain

• 42 Reaction vessels with a capacity ranging from 1,000 to 20,000 in AISI 316 or glass-lined; 11 centrifuges in AISI, Halar-AISI or Hastelloy

• 3 Press filters• ID11-B1/B centrifuge and dryer in closed loop with direct loading system

SAFETY & ENVIROMENT CordenPharma Bergamo is committed to operating all functions and processes with a continuous performance improvement approach in accordance with the principles of protecting the environment and people. Our Waste Water Biological Treatment plant has been in operation since January 1992, with a capacity of ~5 tons/day of COD (Chemical Oxygen Demand). Our incinerator has been in operation since 1990, and has the capacity to incinerate ~60 tons/day of waste streams. CordenPharma Bergamo’s incineration plant consists of:• A pre-concentration stage• Rotating pyrolysis oven• 2 Incineration ovens• Heat recovery facility (steam generators)

All CordenPharma Bergamo reactors are blanketed with Nitrogen.