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Alkem gets EIR report from USFDA for Baddi facility

Press Trust of India  |  New Delhi 

Drug firm today said it has received an establishment report (EIR) from the US health regulator on closure of of its facility.

The (USFDA) has issued an for the company's located at Baddi, Himachal Pradesh, said in a regulatory filing.

The USFDA had inspected the plant from September 11, 2017 to September 15, 2017.

The company said it had submitted a detailed corrective and preventive action (CAPA) plan to the USFDA within the stipulated time lines in response to the two Form 483 observations issued by the regulator.

"The has now been closed by the USFDA," it added.

USFDA releases a copy of the to the establishment that is subject of an FDA or FDA-contracted inspection when the agency determines the same to be closed.

Alkem today ended 5.74 per cent higher at Rs 2,347.70 apiece on the

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, January 10 2018. 16:05 IST