Natco Pharma Ltd., a key player in India’s pharmaceutical landscape, has confirmed that the U.S. Food and Drug Administration (USFDA) has issued a Form 483 with seven observations following a comprehensive inspection of its Kothur facility near Hyderabad. The inspection, conducted between June 9 and June 19, 2025, scrutinized compliance with current Good Manufacturing Practices (cGMP). Natco has assured stakeholders that it will address the cited observations within the prescribed regulatory timeframe.