Inogent Laboratories (Inogent), a GVK BIO associate company announced today that its GMP compliant facilities in Hyderabad were audited and approved by the Japanese regulator, Pharmaceuticals and Medical Devices Agency (PMDA). 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.”
About Inogent Laboratories Private Limited
Inogent Laboratories Private Limited is ISO 9001 & WHO cGMP certified and is a GVK Biosciences (GVK BIO) associate company based out of Hyderabad, India. Inogent offers an attractive mix of Services (Process R&D and Custom Chemical Synthesis and Manufacturing) and Products (APIs and Intermediates) to its clients. The Company has state-of-the-art process and analytical R&D laboratories, pilot plant, kilo lab, custom synthesis plant and two production blocks. Inogent works with pharmaceutical, generic and biotech companies who have audited and approved its manufacturing and scale up facilities.
Sharada Alvakonda, Dy. General Manager – Corporate Communications, GVK Biosciences Private Limited,