Apicore US LLC.
Apicore US LLC.

GMP Inspections

Apicore US LLC, Somerset, NJ
- US FDA May 2013
- US FDA September 2011
- US FDA July 2010
- US FDA December 2008
- US FDA September 2006
- US FDA November 2005

Apicore Pharmaceuticals, Pvt. Ltd.,
Vadodara, Gujarat, India

- US FDA June 2014
- US FDA September 2011

Customer Inspections

Apicore US LLC, Somerset, NJ Eleven (11) global Pharma MNC’s, which include the top five Generic Pharma companies have successfully audited the Somerset, NJ facility during the period August 2009 thru June 2014.

Apicore Pharmaceuticals, Pvt. Ltd., Fifteen (15) global Pharma MNC’s, which include the top five Generic Pharma companies, have successfully audited the Vadodara, India, facility during the period May 2011 thru June 2014.

Inspected/Accredited By

- USFDA, United States
- MHLW, Japan
- CDSCO, India
- EMEA, TGA, HC and ANVISA inspections awaited
- Third party customer audits for USFDA, HC, TGA, EMEA and ROW submissions

Both sites have had customer audits for US, CA, ROW and European submissions which will fall under MHRA and EDQM.