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Atul Bioscience's Ambernath Plant Passes FDA Inspection with Zero Findings

Atul Bioscience's Ambernath plant passes FDA inspection with zero findings, receives EIR.

Mrudula Kulkarni
By Mrudula Kulkarni
Managing Editor - Pharma Now
Aug 12, 2024Updated Jun 26, 2025 · 2 min read
Atul Bioscience's Ambernath Plant Passes FDA Inspection with Zero Findings
https://www.atulbio.co.in/
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Reviewed by Mrudula Kulkarni, Managing Editor - Pharma Now

The United States Food and Drug Administration (USFDA) provided Atul Bioscience Ltd with an establishment inspection report (EIR) for its manufacturing plant located in Ambernath, Maharashtra.

Following the facility's most recent inspection, which took place from May 6–10, 2024, and resulted in zero FDA 483 findings, the EIR was released.The company's activities include contract manufacturing, intermediate production, and the production and commercialisation of active medicinal ingredients.

"The successful completion of this inspection reflects the dedication and hard work of our entire team," stated Dr. Prabhakar Chebiyyam, Managing Director of ABL.

It fortifies our determination to continually provide pharmaceutical goods of the highest calibre and to further enhance our procedures in order to satisfy the constantly changing demands of the world pharmaceutical market."

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Mrudula Kulkarni
Written by
Mrudula Kulkarni
Managing Editor - Pharma Now

My international experience as a researcher in Taiwan for three years has equipped me with a global perspective, enabling me to create content that resonates with an international audience.



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