Indoco Remedies has received Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (USFDA) for their facility for solid dosages (Plant I) located in Verna, Goa. The recent inspection held from January 16, 2023, to January 20, 2023, was a surveillance inspection.
The receipt of the EIR with VAI status also signifies the imminent closeout of the Warning Letter issued by the USFDA in July 2019 for the manufacturing site, situated at L-14, Verna Industrial Road, Goa (Plant I). Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
