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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...
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.
Read also: Cipla to purchase additional stake in GoApptiv for Rs 26 crore
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751