Natco Pharma’s API plant in Hyderabad gets U.S. FDA observation

Generic drugmaker Natco Pharma’s active pharmaceutical igredients (API) manufacturing plant in Mekaguda, Hyderabad, has been issued a Form 483 with one observation by the U.S. Food and Drug Administration. The U.S. FDA conducted the inspection from June 9-13, and on conclusion, the company received one observation in the Form-483. The company believes it is procedural in nature and is confident to address the observation comprehensively, Natco Pharma said in a filing on Friday.