Shares of Indoco Remedies fell 7% in late morning trade on Monday as 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), 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 in the filing.
The company will respond to the warning letter within the stipulated time and is already working with a cGMP consultant to ensure that the remediation activities are completed in line with the USFDA's expectations, the company added.
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 has one approved ANDA from this site, the annual revenue of which is around Rs3cr. There are four pending ANDAs from this facility and these approvals may be withheld till all the issues are resolved.
Indoco Remedies Ltd is currently trading at Rs161.35, down by Rs8.6 or 5.06% from its previous closing of Rs169.95 on the BSE.
The scrip opened at Rs170.10 and has touched a high and low of Rs172.45 and Rs149 respectively.
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