Alkem Labs gets 8 USFDA observations for St Louis facility
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 manufacturing 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.
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The said product is not being manufactured as it is awaiting approval from USFDA, it added.
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at firstname.lastname@example.org Contact no. 011-43720751 To know about our editorial team click here