The U.S. Food and Drug Administration (USFDA) has concluded the inspection at Natco Pharma’s API manufacturing plant located in Mekaguda, Hyderabad, India. The said inspection was conducted from June 9 to June 13, 2025. On conclusion of the inspection, the Company received 1 observation in the Form 483.
The Company believes that the observation is procedural in nature. The Company is confident to address this observation comprehensively. The company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally.
Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.
