USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
Drug Approval

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received 1 (One) observation in the Form-483

  • By IPP Bureau | June 13, 2025

NATCO Pharma Limited (NATCO) announced conclusion of USFDA Inspection at our Mekaguda, Hyderabad Active Pharmaceutical Ingredients (API) Unit.

The U.S. Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Mekaguda, Hyderabad, India, which was conducted from June 9th - June 13th, 2025.

On conclusion of the inspection, the company received 1 (One) observation in the Form-483. The Company believes that the observation is procedural in nature. The Company is confident to address this observation comprehensively.

NATCO remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally.

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