Rusan Pharma, an India-based pharmaceutical company specializing in 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. The approval, received on May 29, 2024, followed a comprehensive five-day on-site inspection conducted from April 29 to May 3, 2024.
This milestone marks a significant achievement for the company, paving the way for entry into 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, highlighted, “This GMP approval by the USFDA underscores our unwavering commitment to maintaining the highest standards of quality and manufacturing excellence. It expands our global presence and credibility, instilling confidence in our partners and clients, and reassuring them of our dedication to producing high-quality APIs that meet the most stringent global standards.”
The USFDA 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.
Rusan’s API facility in Ankleshwar is also GMP approved by other stringent 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 significant challenges that the company successfully overcame.
Before receiving this approval, Rusan Pharma established a robust presence in key markets such as Australia, Brazil, Canada, the EU, Mexico, New Zealand, and the United Kingdom. The USFDA’s endorsement enables the company to market its APIs to US clients with existing marketing authorizations and those developing new formulations. This approval further bolsters trust and confidence in the company globally.
“Our vision is to be a one-stop solution provider in the niche category of addiction treatment and pain management. Integration with API enables us to remain competitive while promoting our finished formulations in the global market. It also enables us to be independent from other companies for the supply of critical APIs for the manufacturing of various finished formulations, especially for narcotic and psychotropic products. Timely delivery of quality medicine is key to any pharmaceutical business. Hence, a robust supply of API enables us to achieve a rapid time to market with critical products,” added Dr. Kunal Saxena.
Rusan’s Ankleshwar manufacturing unit’s strategic role in its manufacturing and distribution network is underscored by its focus on critical APIs like fentanyl and buprenorphine. The company’s vision is to be a comprehensive addiction treatment and pain management provider, ensuring competitive and timely delivery of quality medicines.
