scorecardresearchIndia's Sun Pharma says Halol facility listed under FDA import alert
Mintgenie

India's Sun Pharma says Halol facility listed under FDA import alert

Team MintGenie
Updated: 08 Dec 2022, 12:01 PM IST
TL;DR.

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

FILE - A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. Expedited drug approvals slowed in 2022, as the FDA's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in the year, the agency’s drug center has granted 10 accelerated approvals — fewer than the tally in each of the last five years, when use of the program reached all-time highs. (AP Photo/Manuel Balce Ceneta, File)

FILE - A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. Expedited drug approvals slowed in 2022, as the FDA's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in the year, the agency’s drug center has granted 10 accelerated approvals — fewer than the tally in each of the last five years, when use of the program reached all-time highs. (AP Photo/Manuel Balce Ceneta, File)

(Reuters) The U.S. Food and Drug Administration (FDA) had listed Indian drugmaker Sun Pharmaceutical Industries Ltd's facility in the western Indian state of Gujarat under an import alert, the company said on Thursday, sending its shares down 3.6%.

The import alert means all future shipments of products made at the Halol plant can be refused admission to the U.S. market until the facility becomes compliant with the FDA's Current Good Manufacturing Practice standards, Sun Pharma said in a statement.

"The company continues to cooperate with the U.S. 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," Sun Pharma said.

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

It was not immediately clear what the conditions are and what remedial action the FDA had asked the company to take. Sun Pharma did not immediately respond to Reuters' request for further comment.

Supplies to the U.S. market from Halol contributed to about 3% of Sun Pharma's consolidated revenue in the year ended March 2022, including the 14 excluded products.

The company's shares posted their sharpest intraday percentage drop since end-May following the news and were the top loser on the blue-chip Nifty 50 index.

First Published: 08 Dec 2022, 10:34 AM IST

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