Zydus' Ambernath API Plant Clears USFDA Inspection with Zero Observations
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Ahmedabad: Zydus Lifesciences Limited has announced the successful completion of a USFDA surveillance inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility in Ambernath, Maharashtra.
The inspection, conducted from February 10 to 14, 2025, concluded with zero observations, reflecting the company’s adherence to stringent regulatory and quality standards.
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In a regulatory filing with BSE Limited and NSE, Zydus Lifesciences stated that this outcome reinforces its commitment to maintaining high compliance standards in its manufacturing operations. The company disclosed the development under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
The closure of the inspection without any adverse remarks from the U.S. Food and Drug Administration (USFDA) is a positive development for Zydus, as compliance with global regulatory agencies plays a crucial role in its API manufacturing and exports.
