Indoco Remedies receives EIR for Goa facilities

Indoco Remedies has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its sterile facility (Plant II) and solid dosages facility (Plant III), located at Verna, Goa.
 
The inspection was carried out at the facilities during the period from October 7 to15, 2019. It was a pre-approval inspection for a sterile injectable product, which ended with 2 observations on Form 483s. The USFDA classified the inspection of the site as Voluntary Action Indicated (VAI). This is the second successful Pre-approval Inspection (PAI) at the company’s facility site in less than 6 months, which further indicates steady progress in the review of Indoco’s pending ANDAs. Indoco Remedies currently has 39 ANDAs pending for approval from this site.
 
In the press release, Ms. Aditi Kare Panandikar, the managing director of Indoco Remedies Ltd., said that the company will remain committed to meeting and exceeding the standards set by the regulatory agencies, globally.
 
Indoco Remedies Limited is a research-oriented pharma company.
 
On Monday, at 10 am, the stock was trading at Rs. 155, up by 3.71 per cent or Rs. 5.55 per share. The 52-week high is Rs. 238 and the 52-week low is Rs. 133.10 on BSE.