BRIEF—Lupin's Tarapur API plant cleared on 'sartans' production by US FDA

Indian drugmaker Lupin announced today the completion of a current Good Manufacturing Practices (cGMP) inspection carried out by the US Food and Drug Administration at its Tarapur facility.

The inspection closed with one observation, a procedural deficiency.

The inspection at the site was conducted between August 27 and 28, 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.

Notwithstanding, Lupin’s share were trading down 1.78% at 919.45 rupees by early afternoon trading in India.