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Indoco Remedies surges 20% on USFDA report for Goa facility

The inspection was held from May 27, 2019 to June 04, 2019, where the company had received 4 observations (483s).

July 26, 2019 / 01:31 PM IST
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Shares of Indoco Remedies surged nearly 20 percent intraday on July 26 as the company received EIR from USFDA.

The company has received the establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) for their sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa, as per the company's BSE release.

The inspection was held from May 27, 2019, to June 04, 2019, where the company had received 4 observations under Form 483

The company has 33 ANDAs pending for approval, out of which, 17 are for ophthalmics, 5 are for injectables and 11 are for solid dosages from the site, it added.

Aditi Kare Panandikar, Managing Director - Indoco Remedies said, "We are happy to receive the EIR in less than two months from the date of inspection. This is encouraging, as the site has been endorsed with the VAl status twice this year, by the US Regulators. The recent inspection was a pre-approval inspection for 3 ANDAs of injectable products filed through our partners."

At 1319 hrs, Indoco Remedies was quoting at Rs 176.10, up Rs 23.05, or 15.06 percent on the BSE.

Moneycontrol News
first published: Jul 26, 2019 01:31 pm

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