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Indoco Remedies receives EIR from USFDA for Goa facility, shares jump 5%

Updated : November 25, 2019 09:32 AM IST

Indoco shares advanced as much as 5.4 percent to Rs 157.55 per share intraday on the BSE.

The inspection was carried out between October 7 to 15 and was classified as VAI (Voluntary Action Indicated) by the USFDA.

Shares of Indoco Remedies rallied over 5 percent on Monday after it received an establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) for its sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa. Indoco shares advanced as much as 5.4 percent to Rs 157.55 per share intraday on the BSE.

The inspection was carried out between October 7 to 15 and was classified as VAI (Voluntary Action Indicated) by the USFDA.

At 9:20 am, the stock gained 5.05 percent to trade at Rs 157 on the Bombay Stock Exchange.

This was a pre-approval inspection for a sterile injectable product, with two observations on Form 483s, which is now concluded as closed, the company said in a regulatory filing on Monday.

"This second successful PAI (Pre-Approval Inspection) at the site in less than 6 months indicates steady progress in review of Indoco’s pending ANDAs. The Company has 39 ANDAs, pending for approval from this site," said Aditi Kare Panandikar, Managing Director, Indoco Remedies Ltd.

Indoco Remedies receives EIR from USFDA for Goa facility, shares jump 5%

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