21 August 2012 | Regulatory | By BioSpectrum Bureau
Inogent Lab gets Japan regulatory body approval
Pharmaceuticals and Medical Devices Agency audited the Hyderabad facility
Hyderabad: Inogent Laboratories, a GVK BIO associate company, has received approval from the the Japanese regulator for its GMP compliant facilities in Hyderabad. The facilities were audited and approved by Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
The PMDA conducts scientific reviews of marketing authorization application of pharmaceuticals and medical devices and monitoring of their post-marketing safety.
Kiran Kumar R, president, Inogent Laboratories, said, "A four member team from PMDA, Japan, visited and audited Inogent's facility, processes and quality management system and approved us without any major observations. We are pleased with the outcome of this audit and expect greater penetration into the Japanese market."
Inogent Laboratories is a ISO 9001 & WHO cGMP certified associate company of GVK Biosciences (GVK BIO) in India and offers a mix of services and products to its clients.