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
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]