USFDA completes inspection of Natco's Kothur formulation facility
Hyderabad: Natco Pharma Limited has announced the completion of a Pre-approval inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Kothur village, near Hyderabad, India, which was conducted from 2nd March to 6th March 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.
The company will provide due justification and corrective action plan with in the next 15 working days to address this observation.
Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, Natco today has seven manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in New Drug Development, etc. Natco is well recognized for its innovation in Pharmaceutical R&D.
Medical Dialogues had earlier reported that Drug firm Natco Pharma had said it had received establishment inspection report (EIR) from the US health regulator for its Kothur facility in Telangana.