Rusan Pharma’s API plant in Ankleshwar receives (India) USFDA GMP approval
IMT News Desk
The approval followed a comprehensive five-day on-site inspection conducted from April 29 to May 3, 2024
Rusan Pharma announced that the United States Food and Drug Administration (US FDA) has granted Good Manufacturing Practice (GMP) approval for its Active Pharmaceutical Ingredient (API) facility in Ankleshwar, Gujarat. The approval followed a comprehensive five-day on-site inspection conducted from April 29 to May 3, 2024.
Dr Kunal Saxena, MD, Rusan Pharma, highlights, "This GMP approval by the US FDA underscores our unwavering commitment to maintaining the highest standards of quality and manufacturing excellence, expanding our global presence and credibility. This achievement instils confidence in our partners and clients, reassuring them of our dedication to excellence in producing high-quality APIs that meet the most stringent global standards.”
The US FDA approval of the Ankleshwar facility is a critical development in Rusan Pharma's strategy to become a key player in the global pharmaceutical industry. Currently, the company supplies APIs to various US-based companies focused on orphan drugs, addiction treatment, and obesity medications. The approval will further enhance Rusan's capabilities, expand its API product portfolio, and increase its footprint in the growing US pharmaceutical sector.
