The United States Food and Drug Administration (USFDA) has completed a regulatory inspection of Natco Pharma’s Formulation facility in Kothur Village, near Hyderabad, India, which was conducted during the period May 30, 2019 to June 05, 2019.
At the end of the inspection, the facility received nine observations, with no repeat observations and mostly procedural in nature. The company believes that none of observations are related to data integrity and that all of the observations can be addressed within a short period of time.
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.
