Lupin Mandideep facility gets GMP certificate from Japanese agency PMDA

Pharmaceutical and Medical Devices Agency (PMDA) inspection closed with no critical or major observations. The GMP Certificate issued by the Japanese agency for Mandideep facility (Unit II) is valid till September 2024, it added.

New Delhi: Homegrown pharma major Lupin on Wednesday said it has received GMP Certificate from Pharmaceutical and Medical Devices Agency, Japan for its Mandideep active pharmaceutical ingredients (API) facility.

The GMP (good manufacturing practice) Certificate was issued following an inspection conducted by PMDA between May 14, 2019, and May 17, 2019, Lupin said in a regulatory filing.

Pharmaceutical and Medical Devices Agency (PMDA) inspection closed with no critical or major observations. The GMP Certificate issued by the Japanese agency for Mandideep facility (Unit II) is valid till September 2024, it added.

Also Read: Lupin Mandideep facility red-flagged by USFDA for CGMP violations

Lupin develops and sells a wide range of branded and generic formulations, biotechnology products and APIs globally.

It is a significant player in therapeutic areas of cardiovascular, diabetology, asthma, pediatric, anti-infective and NSAID space among others besides being a global leader in the anti-TB segment.