Indoco Remedies has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) 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, India, in October 2023. The Company had addressed the observations comprehensively and within the stipulated time. The receipt of the Establishment Inspection Report 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.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1521.95 |
Dr. Reddys Lab | 6279.95 |
Cipla | 1407.55 |
Zydus Lifesciences | 963.50 |
Lupin | 1640.30 |
View more.. |