USFDA lists Sun Pharma's Halol unit under 'import alert', stock falls 2.5%

Sun Pharmaceutical Industries' stock fell 2.5% on Thursday as the US Food and Drug Administration (FDA) had listed the drugmaker's facility in Gujarat's Halol under an import alert.

At 10:40 hours on Thursday, the drugmaker's stock was trading 2.5% lower at Rs 991.3.

The import alert means all future shipments of products made at Halol can be refused admission to the US market until the facility becomes compliant with the FDA's Current Good Manufacturing Practice standards, the company said in a stock exchange filing. 

The USFDA has excluded 14 products from this import alert subject to certain conditions.

For the year ended March 31, 2022, supplies to the US market from the Halol facility accounted for approximately 3% of the company’s consolidated revenues, including the 14 excluded products. "The company continues to cooperate with the USFDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company’s remedial action," said Sun Pharma in a stock exchange filing.

Sun Pharmaceutical Industries reported 10.5% year-on-year (YoY) rise in net profit at Rs 2,262.20 crore in the September quarter compared with Rs 2,047.01 crore in the same quarter last year. The drug maker said its profit growth was hit by lower other income. 

Gross sales for the quarter came in at Rs 10,809 crore, up 13.1%. The India formulation sales stood at Rs 3,460 crore, up 8.5% YoY while the US formulation sales including that of Taro's came in at $412 million, up 14.1%.