Natco Pharma Receives One Observation in US FDA Inspection at API Manufacturing Plant in Hyderabad

Natco Pharma Limited, a Hyderabad-based pharmaceutical company, announced the conclusion of a U.S. Food and Drug Administration (FDA) inspection at its Active Pharmaceutical Ingredients (API) manufacturing plant located in Mekaguda, Hyderabad, India. The inspection, which took place from June 9th to June 13th, 2025, resulted in one observation in the Form-483. The company believes that the observation is procedural in nature and is confident in its ability to address it comprehensively. Natco Pharma remains committed to being cGMP compliant and supplying high-quality products to its customers and patients globally.