USFDA completes pre-approval inspection of BHL's Vadodara facility
Drug Approval

USFDA completes pre-approval inspection of BHL's Vadodara facility

The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited

  • By IPP Bureau | November 21, 2022

Bajaj Healthcare Limited (BHL), a leading manufacturer of APIs, Intermediates and Formulations, has successfully completed the first ever pre-approval inspection of United State Food and Drug Administration (USFDA) of its API facility located at Vadodara, Gujarat.

The US Food and drug administration (USFDA) has conducted pre-approval inspection of Bajaj Healthcare's API facility located at Vadodara, Gujarat from November 14 -17, 2022.

The pre-approval inspection of United State Food and Drug Administration (USFDA) was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited.

Commenting on the above business update, Anil Jain, Joint Managing Director, Bajaj Healthcare said, “I am happy to announce that we successfully completed the first ever pre-approval USFDA inspection with ZERO 483 observation at our API Manufacturing facilities located at Vadodara, Gujarat. We are committed to strict adherence to all applicable guidelines and regulations and maintaining the highest quality standards in delivering quality services and timely delivery to our clients.”

Bajaj Healthcare Limited, a leading manufacturer of APIs, Intermediates and Formulations, has state-of-art manufacturing facilities, of which six units are dedicated to APIs, two units to Intermediates and one unit for formulation. These facilities are designed to meet the requirements of both advanced as well as emerging market opportunities. BHL has a strong presence globally in countries like Europe, USA, Australia, Africa, Middle East, and South America.

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