Sun Pharma slips nearly 4% as USFDA issues import alert on Halol facility

Shares of Sun Pharmaceutical Industries slipped 3.5 per cent to Rs 981.50 on the BSE in Thursday’s intra-day after the company said that the US health regulator has put its manufacturing facility at Halol under import alert.

The company has received a communication from the US Food and Drug Administration (USFDA) stating that the facility has been listed under Import Alert, Sun Pharma said in an exchange filing. USFDA had inspected the company’s Halol (Gujarat) facility from April 26 to May 9, 2022.

The import alert implies inter alia, that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with Current good manufacturing practices (cGMP) standards. The USFDA has excluded 14 products from this Import Alert subject to certain conditions, the company said.

For the year ended March 31, 2022, supplies to the US market from the Halol facility accounted for approximately 3 per cent of the Company’s consolidated revenues, including the 14 excluded products as mentioned above.

Sun Pharma further said that 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.

Sun Pharma remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally, the company said.

At 10:41 am; shares of Sun Pharma quoted 2.6 per cent lower at Rs 991.20, as compared to 0.11 per cent rise in the S&P BSE Sensex. The average trading volumes on the counter more-than-doubled with a combined 3.4 million shares changing hands on the NSE and BSE.