Lupin Gets 1 Observation for Tarapur Facility After USFDA cGMP Inspection
Mumbai: Pharma major Lupin has announced the completion of a cGMP inspection carried out by the United States Food and Drug Administration (USFDA) at its Tarapur facility. The inspection closed with one observation, a procedural deficiency.
The inspection at the site was conducted between 27th and 31st August 2018 by three FDA investigators.
The inspection focused on cGMP compliance and also on the safety of Lupin’s Valsartan, Losartan and Irbesartan APIs (commonly known as ‘Sartans’) in light of the safety alert issued by Regulatory Authorities on the NDMA (classified as a probable human carcinogen) impurity in Valsartan API supplied by some companies.
During the inspection, the US FDA concluded that the manufacturing processes of Lupin ‘Sartans’ are safe with no chance of presence of the NDMA impurity in the APIs.
Lupin is a pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company 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.
