Cipla Indore plant gets 2 USFDA observations

Written by Ruchika Sharma Published On 2022-07-05T12:17:18+05:30 | Updated On 5 July 2022 12:17 PM IST

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.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

"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.

Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai.

Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions.

Read also: Cipla, Macleods HIV child treatments approved in South Africa

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent 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