Alembic Pharma gets USFDA EIR for Karakhadi facility

Published On 2021-10-12 08:46 GMT | Update On 2021-10-12 08:46 GMT

Gujarat: Drugmaker, Alembic Pharma, has announced that the company has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out at its New Injectable Facility (F-3) at Karakhadi, Gujarat.

"The company has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out by them at our New Injectable Facility (F-3) at Karakhadi during the period from 28th January, 2021 to 5th February, 2021, indicating that the USFDA finds our responses to their observations to be adequate," the company said in a BSE filing.

The inspection was conducted from 28th January, 2021 to 5th February, 2021.

USFDA has also indicated that a compliance verification would be performed during re-inspection of the said facility in the next review cycle.

In February, Alembic Pharma had got five observations from US health regulator after inspection at its facility at Karkhadi, Gujarat.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.

Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Alembic Pharma gets USFDA EIR for Karakhadi facility

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