You are here: Home » News-CM » Companies » News
Business Standard

Alkem Laboratories update on USFDA inspection of its facility in St. Louis, USA

Capital Market 

Alkem Laboratories announced that with reference to the USFDA inspection of its facility at St. Louis, USA, the company had submitted a detailed response to the eight (8) Form 483 observations that it had received during a pre-approval inspection for a product at the Company's manufacturing facility located at St.

Louis, USA.

The Company has now received a letter from the 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 the USFDA shall be communicated to the Company accordingly. It is to be noted that the said product is not being manufactured at this time as it is awaiting approval from US FDA.

Powered by Capital Market - Live News

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

First Published: Fri, March 22 2019. 15:26 IST
RECOMMENDED FOR YOU
RECOMMENDED FOR YOU