Natco Pharma receives 7 observations from FDA inspection at Chennai API unit

Natco Pharma Limited reported the conclusion of a US FDA inspection at its Manali, Chennai Active Pharmaceutical Ingredients (API) unit. The inspection, which took place from November 17th to November 21st, 2025, resulted in the company receiving seven observations in Form-483.

Natco Pharma stated that the observations are procedural in nature and expressed confidence in comprehensively addressing them. The company reaffirmed its commitment to cGMP compliance and to supplying high-quality products to its customers and patients globally.

Natco Pharma is headquartered in Hyderabad, India, and specializes in developing, manufacturing, and distributing generic and branded pharmaceuticals, as well as active pharma ingredients and crop protection products.