Lupin's Pithampur unit gets inspection closure report from USFDA

Pithampur Unit-3 facility is involved in the manufacture of metered dose inhalers.

BCCL
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.
NEW DELHI: Drug major Lupin Ltd 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 closed 1.40 per cent higher at Rs 776.85 apiece on BSE.
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