Indoco Remedies tumbles after USFDA warning letter for Goa plant

Indoco Remedies dropped 5.09% to Rs 161.3 at 12:24 IST on the BSE after the company said that its Goa plant I received warning letter from the US drug regulator.

The announcement was made during market hours on Monday, 15 July 2019.

Meanwhile, the S&P BSE Sensex was down by 8.85 points or 0.02% to 38,727.38.

On the BSE, 14,000 shares were traded in the counter so far compared with average daily volumes of 1796 shares in the past two weeks. The stock had hit a high of Rs 172.45 and a low of Rs 149 so far during the day. It hit a 52-week high of Rs 238 on 26 November 2018 and a 52-week low of Rs 134.1 on 20 June 2019.

Indoco Remedies has received a warning letter from the United States Food and Drug Administration (USFDA) for its oral dosages plant, situated at Goa (plant I), as a result of the inspection carried out in January 2019. 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 company said it will respond to the warning letter within stipulated time and is already working with cGMP (Current Good Manufacturing Practice) consultant to ensure that the remediation activities are completed in line with the USFDA's expectations. The company has one approved ANDA (Abbreviated New Drug Application) from this site, the annual revenue of which is around Rs 3 crore. There are four pending ANDAs from this facility and these approvals maybe withheld till all the issues are resolved.

The company's managing director, Aditi Kare Panandikar, said, "We have already done considerable remediation work and shall continue to implement necessary additional corrective actions. We are committed to being cGMP compliant and supplying quality products to our customers and the patients across the globe."

Indoco Remedies net profit fell 43.3% to Rs 11.63 crore on 5.4% decline in net sales to Rs 244.97 crore in Q4 March 2019 over Q4 March 2018.

Indoco Remedies is a fully integrated, research-oriented pharma company with presence in 55 countries.

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