USFDA issues 4 observations to Alembic Pharma's Panelav facility; stock dips ~2%

18 Oct 2022 , 01:51 PM

Alembic Pharmaceuticals Limited informed that the United States Food and Drug Administration (USFDA) inspected the company’s Oncology Injectable Formulation Facility in Panelav between October 4 to October 14, 2022.

USFDA issued a Form 483 with 4 procedural observations.

“Management feels that none of the findings are connected to data integrity and that they can be addressed by the company,” said the company in its exchange filing.

The company is now drafting a response to the observations, which will be submitted to the USFDA within the timeframe specified.

The company said that it is committed to maintaining the highest quality standards and compliance at all times.

At around 1.55 PM, Alembic Pharmaceuticals was trading at Rs560.05 down by 1.66% from its previous closing of Rs569.50 on the BSE. The scrip touched intraday high and low of Rs572.85 and Rs557.60 respectively.

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