Indoco Remedies receives EIR from USFDA for Goa facility
NewsDrum Desk
03 May 2023
New Delhi, May 3 (PTI) 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 anestablishment.
The company has received an EIR with Voluntary Action Indicated (VAI) status from USFDA for itsfacility 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 agencyis 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 letterissued 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 ofabbreviated new drug applications (ANDAs)
submitted from this site.
"We are committed to maintaining strict adherence to the highest quality standards and toensuring delivery of safe and effective generic
medicines to our patients in the US and around theworld," 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. PTI MSS ANU
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