Natco Pharma Ltd 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. The inspection was conducted from March 2 to 6.
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 soon.
The company will provide justification and corrective action plan within the next 15 working days to address this observation, Natco informed in a statement.