Indoco Remedies gets USFDA EIR for oral dosage facility at Goa plant I
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-01-23 09:29 GMT | Update On 2024-03-26 09:46 GMT
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Mumbai: Indoco Remedies Limited has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (U.S. FDA) for the Pre-Approval Inspection (PAI) conducted for the oral dosage form at the manufacturing facility located at Goa Plant-I, L-14 Verna Industrial Area Verna, Goa, 403722, India, in October 2023.
The Company had addressed the observations comprehensively and within the stipulated time. The receipt of the Establishment Inspection Report (EIR) indicates a successful closure of the inspection. The PAI was conducted for two drug product applications (ANDAs) filed from this facility, for which approvals are expected soon.
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