Natco Pharma gets 7 USFDA observations for Chennai facility
Hyderabad: Natco Pharma has announced that the company has received seven observations from the U.S. Food and Drug Administration (FDA) after an inspection at its API manufacturing plant located in Manali, Chennai, India.
The inspection was conducted from November 17th – November 21st, 2025.
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.
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NATCO Pharma Limited is a public limited company, listed on the Bombay Stock Exchange and the National Stock Exchange of India, with a market capitalisation of c. US$ 2 billion. Established in 1981, NATCO Pharma has evolved into a diversified pharmaceutical manufacturer, with a primary focus on research and development, manufacturing, and global marketing of both finished dosage formulations and active pharmaceutical ingredients. NATCO Pharma operates across various geographies (in over 50 countries), including emerging and developed markets, with a particular focus on delivering quality medicines in oncology, cardiology, neurology, and other high-value therapeutic categories.
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