Lupin gets nod from USFDA for Pithampur unit

PTI Updated - April 02, 2019 at 12:59 PM.

Drug major Lupin Ltd on Tuesday announced receipt of the Establishment Inspection Report (EIR) from the US health regulator for its Pithampur facility in Madhya Pradesh.

The US Food and Drug Administration (USFDA) gives EIR on closure of inspection of an establishment that is the subject of an USFDA or USFDA-contracted inspection.

“The inspection was conducted between October 8, 2018 to October 18, 2018,” the company said in a BSE filing.

Lupin said its Pithampur Unit-3 facility is involved in the manufacture of metered dose inhalers (MDis), dry powder inhalers (DPis) and topical formulations for the regulated markets.

Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “Receiving the EIR for our Pithampur Unit-3 facility is a very positive development and brings us one step closer to bringing important MDis and DPis to the market. We are committed to ensuring the quality, safety and efficacy of the products that we manufacture across our facilities.”

Shares of Lupin were trading 1.40 per cent higher at Rs 776.85 on BSE.

Published on April 2, 2019 07:29