1. Alembic Pharma receives EIR report from USFDA

Alembic Pharma receives EIR report from USFDA

Drug firm Alembic Pharmaceuticals has received the Establishment Inspection Report from the US health regulator for its formulation facility located at Panelav in Gujarat.

By: | New Delhi | Updated: October 5, 2016 12:56 PM
In March this year, the company received four observations from the US health regulator after the inspection of Panelav facility. ( Reuters) In March this year, the company received four observations from the US health regulator after the inspection of Panelav facility. ( Reuters)

Drug firm Alembic Pharmaceuticals has received the Establishment Inspection Report from the US health regulator for its formulation facility located at Panelav in Gujarat.

“The company’s formulation facility located at Panelav has received the Establishment Inspection Report (EIR) from US Food and Drug Administration (FDA) for the inspection carried out by them in March 2016,” Alembic Pharmaceuticals said in a BSE filing.

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

In March this year, the company received four observations from the US health regulator after the inspection of Panelav facility.

The company, however, did not provide any details about the observations it has received from USFDA.

According to the company’s website, formulation accounts for around 65 per cent of the total business for Alembic Pharmaceuticals. It has three manufacturing facility for formulations — Vadodara and Panelav at Gujarat and Baddi in Himachal Pradesh.

The stock of Alembic Pharmaceuticals was trading at Rs 684.55, up 3.70 per cent, from its previous close on BSE.

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