Indoco Remedies dives 12% on USFDA warning letter for Goa plant

The inspection of oral dosages plant at Goa was carried out by the US Food and Drug Administration in January 2019.

Shares of pharma company Indoco Remedies plunged 12 percent intraday on July 15 after its Goa plant received a warning letter from the US health regulator.


The inspection of oral dosages plant at Goa was carried out by the US Food and Drug Administration in January 2019.

The company in its BSE filing said it would respond to the warning letter within the stipulated time and is already working with current good manufacturing practice consultant to ensure that the remediation activities are completed in line with the USFDA's expectations.

The company further said it has one approved ANDA from this site, the annual revenue of which is around Rs 3 crore. "There are four pending ANDAs from this facility and these approvals may be withheld till all the issues are resolved."

The facility had received 6 observations in Form 483s and was classified as OAI (Official Action Indicated) in March 2019. The company responded to these observations with a detailed remediation plan, the implementation of which is still on-going.

The stock was quoting at Rs 157.85, down Rs 12.10, or 7.12 percent on the BSE at 1136 hours IST.

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