The US FDA sent Atul Bioscience Ltd an EIR for its Ambernath facility.

Mumbai, Maharashtra, India

Atul Bioscience Ltd (ABL), a 100% subsidiary company of Atul Ltd, 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.”

About ABL

ABL is engaged in the manufacturing and marketing of APIs and their intermediates for different therapeutic areas, particularly antiasthmatic, antidepressant, antidiabetic, antifungal, anti-infective, anti-inflammatory, antineoplastic, antiretroviral and cardiovascular, as well as contract manufacturing operations. It has plants located at Atul in Gujarat and Ambernath in Maharashtra.