ANKLESHWAR, India--(BUSINESS WIRE)--Jul 22, 2024-- RUSAN PHARMA PRIVATE LIMITED , a pharmaceutical company based in India specializing in the area of addiction treatment and pain management, recently announced that the United States Food and Drug Administration (USFDA) has granted Good Manufacturing Practice (GMP) approval for its Active Pharmaceutical Ingredient (API) facility in Ankleshwar (Gujarat, India). The approval, received on May 29, 2024, followed a comprehensive five-day on-site inspection conducted from April 29 to May 3, 2024. This press release features multimedia.
View the full release here: https://www.businesswire.com/news/home/20240718239433/en/ Rusan Pharma's API facility in Ankleshwar, Gujarat, India (Photo: Business Wire) This milestone marks a significant achievement for the company as it paves the way for it to enter the US API market.
With an active US Drug Master File (DMF) for niche APIs like Eflornithine Hydrochloride Monohydrate and Nalmefene Hydrochloride, Rusan Pharma plans to expand its portfolio with additional APIs, including 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.