Lupin gets GMP certificate for Mandideep API facility

Lupin Limited has informed the bourses that it has received GMP (Good Manufacturing Practice) Certificate from the Pharmaceutical and Medical Devices Agency (PMDA), Japan for its Mandideep API facility (Unit II).

The GMP certificate was issued following an inspection conducted by PMDA between May 14, 2019 and May 17, 2019. The PMDA inspection closed with no critical or major observations. The GMP Certificate issued by PMDA for Mandideep facility (Unit II) is valid till September 2024.

Last week, the company had launched Mycophenolate Mofetil Capsules USP, 250 mg. Its alliance partner Concord Biotech Limited (Concord) had received an approval from the United States Food and Drug Administration (USFDA) earlier.

Mycophenolate Mofetil Capsules are an anti-metabolite immunosuppressant indicated for the rophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants.

Lupin Limited is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

On Wednesday, the stock of Lupin opened at Rs. 667.70. During the morning trading session, it was up by 1.7 per cent to Rs. 680.00.