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.
Published – June 14, 2025 08:28 pm IST
Source: https://www.thehindu.com/business/natco-pharmas-api-plant-in-hyderabad-gets-us-fda-observation/article69694202.ece
