Indoco Remedies 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), 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.
Commenting on the development, Ms. Aditi Kare Panandikar, Managing Director, said that "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."
The Company will respond to the Warning Letter within stipulated time and is already working with cGMP 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.
Shares of INDOCO REMEDIES LTD. was last trading in BSE at Rs.171 as compared to the previous close of Rs. 167.6. The total number of shares traded during the day was 3758 in over 274 trades.
The stock hit an intraday high of Rs. 171 and intraday low of 163.45. The net turnover during the day was Rs. 628809.