“The company has received a warning letter from the United States Food and Drug Administration (USFDA) for its Oral dosages Plant, situated at L -14, Verna Industrial Road, Goa (Plant I),” Indoco Remedies said in a regulatory filing.
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, it added.
Indoco Remedies 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 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.
At 11:36 am; the stock was down 9 per cent to Rs 155 on the BSE, as compared to 0.10 per cent rise in the S&P BSE Sensex. The trading volumes on the counter jumped more than six-fold with a combined 151,669 shares changed hands on the BSE and NSE so far.