Natco Pharma announced the conclusion of a US FDA inspection at its Active Pharmaceutical Ingredients (API) manufacturing unit in Manali, Chennai. The inspection, conducted from November 17th – November 21st, 2025, resulted in seven observations. The company believes these observations are procedural and is confident in addressing them. Natco Pharma remains committed to supplying high-quality products.
FDA Inspection Update
Natco Pharma has completed a US Food and Drug Administration (FDA) inspection at its Active Pharmaceutical Ingredients (API) manufacturing facility located in Manali, Chennai. The inspection took place between November 17th and November 21st, 2025.
Inspection Findings
Following the inspection, Natco Pharma received seven observations in the Form-483. The company views these observations as procedural. Natco Pharma is confident in its ability to address these observations effectively and comprehensively.
Commitment to Quality
Natco Pharma emphasizes its ongoing commitment to maintaining cGMP compliance and providing high-quality pharmaceutical products to customers and patients globally.
Source: BSE
