Natco Pharma gets 7 USFDA observations for Chennai facility

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.

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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