USFDA9 Aug 2024, 10:14 pm
Atul Bioscience Ltd Receives EIR from US FDA for Ambernath Facility with Zero Observations
AI Summary
Atul Bioscience Ltd (ABL), a 100% subsidiary of Atul Ltd, has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility in Ambernath, Maharashtra. The EIR was issued after the last inspection conducted from May 06, 2024, to May 10, 2024, which concluded with zero FDA 483 observations. ABL is engaged in manufacturing and marketing of active pharmaceutical ingredients (APIs), their intermediates and contract manufacturing operations.
Key Highlights
- ABL receives EIR from US FDA for Ambernath facility
- Zero FDA 483 observations in the last inspection
- ABL is engaged in manufacturing and marketing of APIs, their intermediates and contract manufacturing operations
- The successful completion of the inspection reflects the dedication and hard work of the ABL team
- This achievement strengthens ABL's resolve to deliver high-quality pharmaceutical products consistently and improve processes to meet the global pharmaceutical industry's needs