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Alembic Pharma gets Form 483 with 2 observations from USFDA for Karkhadi facility

The Company is committed to maintain the highest quality standards and compliance at all times.

September 02, 2022 9:16 IST | India Infoline News Service
Alembic Pharmaceuticals Limited has informed to the exchanges regarding USFDA inspection at Alembic Pharmaceuticals Injectable Facility (F-3) at Karkhadi.
As per the filing, the United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals’ Injectable Facility (F-3) situated at Karkhadi from August 18, 2022 to August 30, 2022. The USFDA issued a Form 483 including 2 observations.
"None of the observations are related to data integrity and company's management believes that they are addressable", the company said.
It further added that Alembic is preparing the response to the observations, which will be submitted to the USFDA within stipulated period of time.
The Company is committed to maintain the highest quality standards and compliance at all times.

On Friday early morning trade, Alembic Pharma was trading at 648.25 per share higher by 0.96% on the BSE.

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