Strides Pharma facility receives USFDA warning letter

Strides Pharma has received a warning letter from USFDA for its Puducherry facility. Reacting to this development, the stock of the company fell by 4 per cent.

The United States Food and Drug Administration (USFDA) previously had classified the company’s Puducherry facility as Official Action Indicated (OAI). Relating to this, as further development, the company clarified of receiving a warning letter from the USFDA for the same facility. According to the press release, six Abbreviated New Drug Application (ANDA) being produced at the site won’t have an impact but other 10 ANDAs which are pending approval will be deferred till the site gets reclassified. An ANDA contains data which are submitted to the USFDA for review and seek approval of manufacturing a generic drug product.

Strides Pharma Science Limited is a pharmaceutical company headquartered in Bangalore, India. The company develops, manufactures and markets pharma products for regulated and emerging markets. It has four USFDA approved facilities and two facilities for emerging markets. The company also has an in-house research and development infrastructure in India.

Reacting to this development, the stock of the company closed at Rs. 398, decrease by 3.37 per cent or Rs. 13.90 per share. The 52-week high was Rs. 550.40 and 52-week low was Rs. 340.