Lupin Limited: USFDA completes inspection of Tarapur facility with one observation
The US drug regulator has completed the inspection at Lupin's Tarapur facility with one observation, a procedural deficiency, said the company in a filing to the exchange.
The inspection at the site was conducted between August 27 to 31, 2018 by three FDA investigators.
The inspection was focused on cGMP compliance and also on the safety of Lupin's Valsartan, Losartan and Irbesartan APIs. The USFDA concluded that the manufacturing processes of Lupin 'Sartans' are safe with no chance of the presence of any impurity in the APIs.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biotechnology products and APIs, globally. Lupin is going to be excluded from Nifty 50 from September 28, 2018.
On Tuesday, the stock opened at Rs. 937.55 per share and fell 2 per cent and made an intraday low of Rs. 916 per share, on the BSE.