United States Food & Drug Administration (USFDA) has conducted an inspection at Natco Pharma’s formulations facility in Kothur, near Hyderabad, between January 16-24, 2017. At the end of the inspection, the facility received six observations, all of which are correctable and procedural, and which the company believes are minor in nature. The observations are related to complaint and incident investigations, stability backlog and procedural SOP's.
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.