The US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) at the drug major's Indore plant from 27 June 2022 to 1 July 2022.
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at the said plant. There is no data integrity observation.
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 is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets.
The pharma company's consolidated net profit fell 12.4% to Rs 362 crore on 14.2% increase in total revenue from operations to Rs 5,260 crore in Q4 March 2022 over Q4 March 2021.
Shares of Cipla were up 1.52% to Rs 944.45 on the BSE.
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