Natco Pharma Receives 7 Observations from US FDA Inspection at Hyderabad Division

Natco Pharma Limited, a Hyderabad-based pharmaceutical company, announced the conclusion of a US FDA inspection at its Pharma Division located in Kothur, Hyderabad. The inspection, conducted from June 9th to June 19th, 2025, resulted in the company receiving 7 observations in the Form-483. Natco Pharma is confident in its ability to address these observations within the stipulated timeline. The company remains committed to being cGMP compliant and supplying high-quality products to its customers and patients globally. Natco Pharma Limited is a leading oncology player in the targeted therapies of the domestic market and focuses on limited competition molecule in the US. The company's manufacturing facilities are approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO, and others, catering to over 50 global markets.