Rusan Pharma Secures USFDA GMP Approval for API Facility, Expands US Market Presence

Rusan Pharma Private Limited, a specialist in addiction treatment and pain management pharmaceuticals, has secured Good Manufacturing Practice (GMP) approval from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Ankleshwar, India. This marks a key milestone for the company as it plans to penetrate the US API market.

Rusan Pharma Private Limited, based in India and specializing in addiction treatment and pain management pharmaceuticals, has been granted Good Manufacturing Practice (GMP) approval by the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Ankleshwar.

Secured on May 29, 2024, following a stringent five-day on-site audit, this approval enables Rusan Pharma to expand its reach in the US API market. The company possesses a US Drug Master File (DMF) for niche APIs like Eflornithine Hydrochloride Monohydrate and Nalmefene Hydrochloride, and plans to broaden its portfolio to include Apomorphine, Buprenorphine, and other APIs.

This significant achievement underscores Rusan Pharma's commitment to maintaining top-quality standards. Dr. Kunal Saxena, the Managing Director, stated that the GMP approval reinforces the company's global presence and credibility. Additionally, Rusan Pharma plans to further advance its manufacturing capabilities with a new API facility in Pithampur SEZ, anticipated for GMP inspection by mid-2025.

(With inputs from agencies.)