Last Updated on October 9, 2024 by The Health Master
Bajaj Healthcare
Bajaj Healthcare, a prominent player in the pharmaceutical industry, has recently achieved a significant milestone with the receipt of an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its state-of-the-art manufacturing facility located in Savli, Vadodara, Gujarat.
This commendable achievement underscores the company’s commitment to maintaining high-quality standards in the production of Active Pharmaceutical Ingredients (APIs).
A Thorough Examination:
In a comprehensive Pre-Approval Inspection (PAI) conducted by the USFDA in November 2022, Bajaj Healthcare‘s Savli plant stood the test with flying colors, earning the distinction of receiving Form 483 observations.
This is a testament to the stringent quality control measures and robust processes implemented by the company.
API Manufacturing Excellence:
Bajaj Healthcare‘s Savli facility is dedicated to the production of Active Pharmaceutical Ingredients (APIs), a crucial component in the formulation of various pharmaceutical products.
The receipt of the Establishment Inspection Report (EIR) not only validates the plant’s operational excellence but also affirms its pivotal role in the pharmaceutical supply chain.
Unlocking New Avenues:
Anil Jain, the Joint Managing Director of Bajaj Healthcare, expressed his enthusiasm about this achievement.
According to him, “The receipt of the EIR also opens up the opportunities for filing companies’ own Drug Master Files with the USFDA as well as CDMO opportunities that the company is eyeing with various customers across the globe.”
This development not only solidifies Bajaj Healthcare‘s position in the global pharmaceutical landscape but also paves the way for future collaborations and innovations.
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