Atul Bioscience Receives FDA Approval for Ambernath Facility

Atul Limited has achieved a significant milestone with the receipt of an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (FDA) for its Ambernath, Maharashtra-based manufacturing facility. This positive outcome follows a successful inspection conducted from May 6 to May 10, 2024, which resulted in zero FDA 483 observations.

Atul Bioscience, a wholly owned subsidiary of Atul Limited, manufactures and markets active pharmaceutical ingredients (APIs), their intermediates, and contract manufacturing services. The FDA approval of the Ambernath facility is a testament to the company’s adherence to stringent quality standards and regulatory compliance.

This achievement opens doors for Atul Bioscience to expand its market access in the United States, a major pharmaceutical market. The FDA approval enhances the company’s credibility and positions it as a reliable supplier of high-quality APIs to global pharmaceutical companies.

The receipt of the EIR is a significant boost for Atul Limited’s growth prospects. It validates the company’s commitment to quality and regulatory compliance, strengthening its position in the global pharmaceutical industry.

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 improves our processes to meet the ever-evolving needs of the global pharmaceutical industry.

About Atul Bioscience Ltd

Atul Bioscience Ltd is involved 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.

About Atul Ltd

Atul is a diversified and integrated Indian chemical company. Its products are used in various Industries and are mainly divided into two segments: Life Science Chemicals and Performance and Other Chemicals.

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