US Food and Drug Administration (USFDA) has completed Pre-Approval inspection at Natco Pharma’s formulation facility in Kothur Village, near Hyderabad, India, which was conducted from March 2, 2020 to March 6, 2020.
At the end of the inspection, the facility received a single observation related to equipment qualification of a co-mill used in the process that had operating speed slightly outside the qualification range. The company believes that this is a minor observation and 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.
