Rusan’s API plant in Ankleshwar receives USFDA GMP approval

Rusan Pharmaceuticals, specialising in the area of addiction treatment and pain management, recently announced that the US FDA has granted Good Manufacturing Practice (GMP) approval for its API facility in Ankleshwar, Gujarat. The approval, received on May 29, 2024, followed a comprehensive five-day on-site inspection conducted from April 29 to May 3, 2024.

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.

Currently, the company supplies APIs to various US-based companies focused on orphan drugs, addiction treatment, and obesity medications. With this approval, Rusan aims to expand its API product portfolio and increase its footprint in the growing US pharmaceutical sector.

Following on-site audits, Rusan’s API facility in Ankleshwar is GMP-approved by other international agencies such as Health Canada, the European Union (EU), and ANVISA (Brazil). Rusan implemented 21-CFR-compliant software solutions like SAP, Laboratory Information Management System (LIMS), document and quality management systems (DMS & QMS) and electronic logbooks, ensuring a move towards paperless manufacturing. This transition, along with comprehensive staff training and monitoring, posed challenges that the company overcame.

In November 2023, Rusan Pharma inaugurated its second API manufacturing facility in Pithampur SEZ (Madhya Pradesh, India) with an annual production capacity of up to 400 MT. By mid-2025, the company plans to seek GMP inspection of this new facility by the US FDA and other international inspecting agencies.