Alembic Pharma gets EIR from USFDA for Karakhadi facility

The US regulator has also indicated that a compliance verification would be performed during re-inspection of the said facility in the next review cycle, it added.

By:October 11, 2021 5:33 PM
Bulk-DrugsShares of Alembic Pharmaceuticals closed at Rs 819.45 per scrip on BSE, up 5.42 per cent from its previous close. (File)

Drug firm Alembic Pharmaceuticals on Monday said it has received establishment inspection report (EIR) from the US health regulator for its new injectable facility at Karakhadi in Gujarat.

The company has, “received EIR from US Food and Drug Administration (USFDA) for the inspection carried out by them at our new injectable facility at Karakhadi during the period from January 28, 2021 to February 6, 2021, indicating that the USFDA finds our responses to their observations to be adequate,” Alembic Pharmaceuticals said in a regulatory filing.

The US regulator has also indicated that a compliance verification would be performed during re-inspection of the said facility in the next review cycle, it added.

Shares of Alembic Pharmaceuticals closed at Rs 819.45 per scrip on BSE, up 5.42 per cent from its previous close.

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