This significant milestone, achieved following a comprehensive five-day on-site inspection from April 29 to May 3, 2024, marks a critical step in Rusan Pharma’s expansion into the US API market.
Dr Kunal Saxena, managing director of Rusan Pharma, said: “This GMP approval by the US Food and Drug Administration 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 Ankleshwar facility’s GMP approval allows Rusan Pharma to significantly enhance its presence in the US market, particularly with its active US Drug Master File (DMF) for specialized APIs such as Eflornithine Hydrochloride Monohydrate and Nalmefene Hydrochloride.
Expansion into the US API market
The company plans to expand its API portfolio to include Apomorphine, Buprenorphine, Naloxone, Naltrexone, Nalbuphine, Sodium Oxybate, Clonazepam, Diazepam, Nitrazepam, Oxazepam, and Temazepam.
Rusan Pharma's strategic focus includes supplying APIs to US-based companies involved in orphan drugs, addiction treatment, and obesity medications. The US FDA approval will bolster Rusan's capabilities, allowing it to broaden its API product portfolio and increase its footprint in the US pharmaceutical sector.
The Ankleshwar facility is also GMP approved by other stringent international agencies, including Health Canada, the European Union (EU), and ANVISA (Brazil). Rusan Pharma has implemented 21-CFR-compliant software solutions such as SAP, Laboratory Information Management System (LIMS), document and quality management systems (DMS & QMS), and electronic logbooks to ensure paperless manufacturing. The company faced and overcame significant challenges in transitioning to these systems, including comprehensive staff training and monitoring.
Strategic international certifications
Prior to this approval, Rusan Pharma had established a robust presence in key markets such as Australia, Brazil, Canada, the EU, Mexico, New Zealand, and the United Kingdom. The US FDA's endorsement now enables Rusan to market its APIs to US clients with existing marketing authorizations and those developing new formulations. This approval further strengthens global trust and confidence in Rusan’s products and processes.
“Our vision is to be a one-stop solution provider in the niche category of addiction treatment and pain management,” added Dr. Saxena.
“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 manufacturing various finished formulations, especially for narcotic and psychotropic products. Timely delivery of quality medicine is key to any pharmaceutical business, and a robust supply of API enables us to achieve a rapid time to market with critical products.”
New API manufacturing facility in Pithampur
The Ankleshwar manufacturing unit plays a strategic role in Rusan’s manufacturing and distribution network, particularly for critical APIs like fentanyl and buprenorphine. The company’s vision is to ensure the competitive and timely delivery of quality medicines in addiction treatment and pain management sectors.
In November 2023, Rusan Pharma inaugurated its second API manufacturing facility in Pithampur SEZ, Madhya Pradesh, with an annual production capacity of up to 400 metric tons, significantly higher than the Ankleshwar plant. By mid-2025, the company plans to seek GMP inspection for this new facility by the US FDA and other international inspecting agencies, aiming to further boost its manufacturing capabilities.
Rusan Pharma’s continued expansion and adherence to stringent quality standards underscore its commitment to excellence and its strategic vision of becoming a leading global player in the pharmaceutical industry.
