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USFDA asks Alkem Labs to withhold manufacturing of a product at St Louis facility

Press Trust of India  |  New Delhi 

Drug firm Friday said it has received a letter from the US health regulator asking not to manufacture a at its till a final decision is taken.

The Food and Drug Administration (USFDA) had issued eight observations after inspecting the company's plant at St Louis from January 14 to February 5 this year, said in a filing to BSE.

The company had submitted a detailed response to the eight observations that it had received during the pre-approval inspection for the product, it added.

The company however did not provide any details about the product.

"The company has now received a letter from USFDA informing that the of the said product be withheld until the completion of the final evaluation by the USFDA and the final decision of USFDA shall be communicated to the company accordingly," the drug firm said.

The said product is not being manufactured as it is awaiting approval from USFDA, it added.

Shares of closed at Rs 1,728 per scrip on BSE, down 1.38 per cent from its previous close.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Fri, March 22 2019. 17:15 IST
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