USFDA completes inspection at Alembic Pharmaceuticals’ Solid Oral Formulation Facility

25 Nov 2024 Evaluate

United States Food and Drug Administration (USFDA) has successfully completed inspection at Alembic Pharmaceuticals’ Solid Oral Formulation Facility (F-4) located at Jarod from November 14, 2024 to November 22, 2024. This was a scheduled GMP inspection. The USFDA issued a Form 483 with five procedural observations.

The company will provide comprehensive response to USFDA for the observations within the 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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