Atul Bioscience receives US FDA EIR with zero observations for Ambernath facility

Atul Bioscience, a 100 per cent subsidiary company of Atul, received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility situated in Ambernath, Maharashtra. The EIR was issued post the last inspection of the facility conducted from May 06, 2024, to May 10, 2024 which concluded with zero FDA 483 observations. The Company is engaged in manufacturing and marketing of active pharmaceutical ingredients (APIs), their intermediates and contract manufacturing operations.

Commenting on this achievement, Dr Prabhakar Chebiyyam, Managing Director of ABL, said, “This is a significant milestone for our Company and a testament to our commitment to maintaining quality, safety and compliance in our manufacturing processes.” He further added, “The successful completion of this inspection reflects the dedication and hard work of our entire team. It strengthens our resolve to deliver high-quality pharmaceutical products consistently and further improve our processes to meet the ever-evolving needs of the global pharmaceutical industry.”