Indoco gets EIR from US FDA for its solid dosages facility (Plant I) in Verna, Goa
Our Bureau, Mumbai
Wednesday, May 3, 2023, 12:10 Hrs [IST]
Indoco Remedies Ltd, a fully integrated, research-oriented pharma company, announced the receipt of an Establishment Inspection
Report (EIR) withVoluntary Action Indicated (VAI) status from the US Food and Drug Administration (FDA) 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 US FDA in July 2019 for themanufacturing 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.
Commenting on this positive development, Aditi Kare Panandikar, managing director – Indoco Remedies Ltd., said, "We are
happy to receive the EIRin three and a half months’ time from the date of inspection. It is very encouraging that the site has been
endorsed with VAI status, from (Official ActionIndicated) OAI status, by the US Regulators. We are committed to maintaining strict
adherence to the highest quality standards and to ensuringdelivery of safe and effective generic medicines to our patients in the
US and around the world."
Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma company
with presence in 55 countries.
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