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Apicore LLC, established in 2005, develops and manufactures APIs according to ICH guidelines for new drug development and generic pharma clients. Our kilo-scale manufacturing facility in Somerset, NJ was inspected by FDA in September 2006 and in December 2008. Our R&D lab and GMP pilot plant are op- erational in Vadodara, India. A production plant with 35,000 liters of reactor capac- ity will be completed in Vadodara in 2010. We’re currently a team of 53 people, 28 located in the US and 25 in India. Locations: Somerset, NJ, USA Vadodara, Gujarat, India

Apicore Brochure 22 Feb 09

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Page 1: Apicore Brochure 22 Feb 09

Apicore LLC, established in 2005, develops

and manufactures APIs according to ICH

guidelines for new drug development and

generic pharma clients.

Our kilo-scale manufacturing facility in

Somerset, NJ was inspected by FDA in

September 2006 and in December 2008.

Our R&D lab and GMP pilot plant are op-

erational in Vadodara, India. A production

plant with 35,000 liters of reactor capac-

ity will be completed in Vadodara in 2010.

We’re currently a team of 53 people,

28 located in the US and 25 in India.

Locations: Somerset, NJ, USA Vadodara, Gujarat, India

Page 2: Apicore Brochure 22 Feb 09

Analytical Instrumentation • 5 HPLC’s [ Waters 2790, 2795, Shimadzu 2010 HT]

• 2 GC’s [ Perkin Elmer Headspace GC(Clarus 500),

Shimadzu GC]

• LC/MS/MS [ Waters/Micromass Quattro LC]

• MALLS [Wyatt]

• NMR [ 500 MHz Varian Inova]

• GFC [ Perkin Elmer system with RI detector and

UV/Vis Detector]

• CE [ Beckman PE800 Capillary electrophoresis

system]

• FT-IR

• UV-Visible spectrometer

• Melting & boiling point apparatus

• Autotitrators etc.

• Stability Chambers

Process Research • 7 Chemical hoods (Apicore, USA) • 8 Chemical hoods (Apicore, India)

Apicore, USA R&D and Small-Scale API Manufacturing • Glass, jacketed reactors (30 to 50 liters)

• 20 liter rotary evaporators

• 12 liter to 22 liter glass reaction assemblies

• Column purification

• Filtration Units

• Tray dryers

• Lyophilizer

• Multi-Mill

• Purified water system

Chemistry & Synthesis Capabilities • Carbohydrate chemistry

• Mono, Di and Poly saccharides, including oligosac-

charides

• Nucleoside chemistry

• Potent compounds

• Diagnostic agents

• Liquid APIs

Impurity Profiling • Isolation of impurities from APIs

• Synthesis of impurities

• Structure elucidations

• Full characterization

Apicore, India R&D and Medium-Scale API Manufacturing

• Process and Analytical R&D labs and a GMP Pilot

Plant are fully operational • Construction of a production plant with 35,000

litres of reactor capacity is in progress and sched-

uled to be complete in 2010

For more information about Apicore, please contact:

Ambrose Stafford Vice President, Sales & Marketing Apicore LLC 49 Napoleon Court Somerset, NJ 08873, USA

Phone: +1-(732)-748-8882

Cell: +1-(919)-271-4407

Email: [email protected]