India’s Sun Pharma affected by US FDA import alert on plant

Sun Pharmaceutical Industries Ltd’s drug shipments from its Gujarat plat could be refused entry into its key US market after the drug regulator slapped an import alert on the facility, the drug manufacturer said.

The US Food and Drug Administration’s (FDA) import alert is effectually a ban, implying all forthcoming shipments of products made at the plant in Halol, Gujarat could be refused admission to the US market until the facility becomes compliant with the US regulator’s Current Good Manufacturing Practice Standards.

Shares of the Indian drugmaker slid 3.9% in their sharpest intraday drop since end-May and were the top loser on the blue-chip Nifty 50 index.

Sun Pharma said the firm continues to cooperate with the US FDA 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.

The FDA has omitted 14 products from the import alert, subject to certain conditions.

It was unclear what the conditions were and what remedial action the FDA had asked the drugmaker to take.

After Sun Pharma’s revenue and earnings outlook, and lowered target price by 4.5% to 1,156 rupees, Shrikant Akolkar of Asian Market Securities said import alerts were very tough to remove and several firms were still unable to get their facilities back in compliance after 7-10 years.

Supplies to the US market from Halol including the 14 excluded products, contributed to nearly 3% of Sun Pharma’s consolidated revenue in the year ended March 2022.