NATCO Pharma Limited has confirmed the successful completion of a US FDA inspection at its Active Pharmaceutical Ingredients (API) manufacturing facility in Manali, Chennai. The inspection was carried out from November 17 to November 21, 2025, covering the company’s quality systems, processes, and compliance standards.
At the end of the review, the company received seven observations under Form 483. NATCO mentioned that these findings are procedural in nature and not related to product quality. The management also stated that they are confident about addressing all observations with a comprehensive response.
NATCO reiterated that it remains fully committed to maintaining cGMP compliance and continuing to supply safe, high-quality pharmaceutical products to customers and patients around the world.
