Bajaj Healthcare gets EIR from USFDA for Vadodara facility
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Thane: Bajaj Healthcare Limited (BHL), a manufacturer of APIs, Intermediates and Formulations, has announced the receipt of the Establishment Inspection Report (EIR) from the United State Food and Drug Administration (USFDA), for the Pre-approval inspection that was carried out by the USFDA in November, 2022 at the company's API manufacturing facility in Savli, Vadodara, Gujarat.
"BHL is pleased to inform that the Company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations (No inspectional observations)," the company stated in a BSE filing.
Commenting on the above business update, Mr. Anil Jain, Joint Managing Director, Bajaj Healthcare said: “In line with our previous communication to the exchanges in November 2022 regarding the successful completion of the first-ever pre-approval inspection carried out by the United States Food and Drug Administration (USFDA) at our API facility in Savli, Vadodara, Gujarat, I am pleased to inform you that the Company has now received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) conducted in November 2022. The receipt of the Establishment Inspection Report (EIR) signifies the successful conclusion of the inspection. It serves as a testament to our dedication to upholding global standards of quality and compliance. 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 company is eying with various customers across the globe.”
Bajaj Healthcare Limited, a manufacturer of APIs, Intermediates and Formulations, was established in the year 1993. It specializes in manufacturing of Intermediates, API, formulations & Nutraceuticals. The company has state-of-art manufacturing facilities, dedicated to APIs, Intermediates and formulation. The Company has a strong presence globally in countries like Europe, USA, Australia, Africa, Middle East and South America.
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