Rusan Pharma's API Plant in Ankleshwar Bags USFDA GMP Approval

RUSAN PHARMA PRIVATE LIMITED, a pharmaceutical company headquartered in India that focuses on addiction treatment and pain management, has just confirmed that its Active Pharmaceutical Ingredient (API) facility in Ankleshwar (Gujarat, India) has received Good Manufacturing Practice (GMP) approval from the United States Food and Drug Administration (USFDA). The authorization, granted on May 29, 2024, came after a thorough five-day inspection carried out on site from April 29 to May 3, 2024.

This significant milestone sets the company up to enter the US API market. Having an operational US Drug Master File (DMF) for specialized APIs such as Eflornithine Hydrochloride Monohydrate and Nalmefene Hydrochloride, Rusan Pharma intends to enhance its collection with more APIs like Apomorphine, Buprenorphine, Naloxone, Naltrexone, Nalbuphine, Sodium Oxybate, Clonazepam, Diazepam, Nitrazepam, Oxazepam, and Temazepam.

Speaking on the achievement, Dr. Kunal Saxena, Managing Director of Rusan Pharma, highlights, "This GMP approval by the USFDA 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 approval of the Ankleshwar facility by the USFDA is a crucial step in Rusan Pharma's plan to establish itself as a major player in the worldwide pharmaceutical sector. At the moment, the company provides APIs to multiple American companies specializing in orphan drugs, addiction treatment, and obesity medications. The authorization will further improve Rusan's abilities, broaden its API product range, and expand its presence in the expanding US pharmaceutical industry.