US FDA Issues Two Observations for Cipla’s Plant in Indore, India


The Food and Drug Administration (FDA) of the United States has conducted a pre-approval inspection (PAI) at the company’s plant based in Indore, India from June 27, 2022 to July 1, 2022.

The company has received two observations on FDA Form 483 with respect to the ANDA filed for the product, which is to be produced at the decided plant, and there is no data integrity observation. The PAI is a part of the routine business operations and the company is committed to addressing these observations. It will be submitting its response to the US FDA within the stipulated time.

Cipla is a global pharmaceutical company focused on sustainable and agile growth, deepening its portfolio, and developing complex generics in its home markets of South Africa, North America, India, and other emerging markets across the globe.

The consolidated net profit of the pharmaceutical company has decreased by 12.4 percent on 14.2 increase in the total revenue from the operations in fourth quarter March 2022 over fourth quarter March 2021.

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Cipla is primarily developing medicines to treat cardiovascular disease, respiratory, arthtritis, weight control, depression, diabetes, and several other medical conditions.