Last Updated on December 31, 2023 by The Health Master
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 June 27th, 2022 to July 1st, 2022.
“The Company has received 2 observations on USFDA Form 483 with respect to the 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.
A USFDA 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.
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