Indoco Remedies receives EIR from USFDA for Goa facility

PTI | New Delhi | Updated: 03-05-2023 14:47 IST | Created: 03-05-2023 14:47 IST

Drug firm Indoco Remedies on Wednesday said it has received an Establishment Inspection Report (EIR) from the US health regulator for its Goa-based plant.

The US Food and Drug Administration (USFDA) gives EIR on closure of inspection of an establishment.

The company has received an EIR with Voluntary Action Indicated (VAI) status from USFDA for its facility for solid dosages (Plant I) located in Verna, Goa, Indoco Remedies said in a regulatory filing.

As per USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

The inspection held from January 16-20, 2023, was a surveillance inspection, the drug maker said.

''The receipt of the EIR with VAI status also signifies the imminent closeout of the warning letter issued by USFDA in July 2019 for the manufacturing site,'' it added.

The company said it expects this change in compliance status to pave the way for approvals of abbreviated new drug applications (ANDAs) submitted from this site.

''We are committed to maintaining strict adherence to the highest quality standards and to ensuring delivery of safe and effective generic medicines to our patients in the US and around the world,'' Indoco Remedies Managing Director Aditi Kare Panandikar noted.

Shares of the company were trading 1.9 per cent up at Rs 327.55 apiece on the BSE.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)