Regulatory

GMP Inspections

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

- US FDA June 2014
- US FDA September 2011

Aktinos Pharma Private Ltd.,
Visakhapatnam, Andhra Pradesh, India

- WHO GMP (Local) September 2018
- US FDA October 2018
- US FDA November 2018

Customer Inspections

apicore

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.

Apicore LLC