Cipla Indore plant gets 2 USFDA observations
Mumbai: Pharma major, Cipla, has recently announced that the United States Food and Drug Administration (USFDA) has issued 2 observations after a Pre Approval Inspection (PAI) at the Company's Indore plant.
The inspection was held from 27th June 2022 to 1 st July 2022.
"The Company has received 2 observations on FDA Form 483 with respect to Abbreviated New Drug Application (ANDA) filed for the product to be manufactured at the said plant. There is no data integrity observation," the company said in its recent BSE filing.
"The PAI is part of the routine business operations and the Company is committed to addressing these observations and will submit its response to USFDA within the stipulated time," Cipla stated.
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