By: IPP Bureau
Last updated : June 13, 2025 8:12 pm
The company received 1 (One) observation in the Form-483
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.