USFDA concludes inspection at Alembic Pharma’s injectable facility at Gujarat

01 Sep 2022 Evaluate

United States Food and Drug Administration (USFDA) has concluded inspection at Alembic Pharmaceuticals’ Injectable Facility (F-3) located at Karkhadi, Gujarat. USFDA has conducted inspection from August 18, 2022 to August 30, 2022 and issued Form 483 with 2 observations. None of the observations are related to data integrity and management believes that they are addressable. The company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The company is committed to maintain the highest quality standards and compliance at all times.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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