Bajaj Healthcare Limited (BHL), a leading 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 our API manufacturing facility in Savli, Vadodara, Gujarat.
BHL 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).
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." |
