US FDA Issues 7 Observations To Natco Pharma’s Kothur Unit

Natco Pharma Ltd. on Thursday said the US Food and Drug Administration has issued a Form-483 with seven observations for its pharma division in Kothur, Hyderabad. The inspection was conducted from June 9 to Thursday, the company said in an exchange filing.

The company said it is confident of addressing the observations within the prescribed timeline and reiterated its commitment to cGMP compliance and global supply of high-quality products.