Inogent Laboratories (Inogent), a GVK BIO associate company, announced today that its facilities in Hyderabad were audited and approved by the Japanese regulator, Pharmaceuticals and Medical Devices Agency (PMDA).

Inogent is into contract research & manufacturing services. This development gives the company access to the regulated Japanese market.

Kiran Kumar R., President, Inogent Laboratories, said: “A four-member team from PMDA, Japan visited and audited our facility, processes and quality management system and approved us without any major observations.”

Inogent works with pharma, biotech and research and development companies. It also manufactures active pharmaceutical intermediates, which are catering to the European markets and Turkey.

The facilities, which are expanded post the takeover of Dai ichi Karkaria units in 2005, include pilot plants, kilo labs and two synthesis and production units of multi tonnes.

The company has also approached the US Food and Drug Administration for audit to grow its reach into the regulated markets.

GVK Biosciences is a contract research organisation with global clientele, a company spokesperson said.

>Somasekhar.m@thehindu.co.in

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