Rusan Pharma Private Limited, an Indian pharmaceutical company known for its expertise in addiction treatment and pain management, announced that its Active Pharmaceutical Ingredient (API) facility in Ankleshwar, Gujarat, has received Good Manufacturing Practice (GMP) approval from the United States Food and Drug Administration (USFDA). This prestigious approval was granted on May 29, 2024, following a thorough five-day inspection from April 29 to May 3, 2024.
Strategic Milestone for Global Market Expansion
This significant milestone allows Rusan Pharma to tap into the US API market, leveraging its active US Drug Master File (DMF) for specialized APIs such as Eflornithine Hydrochloride Monohydrate and Nalmefene Hydrochloride. The company plans to broaden its API portfolio with additional products, including Apomorphine, Buprenorphine, Naloxone, Naltrexone, Nalbuphine, Sodium Oxybate, Clonazepam, Diazepam, Nitrazepam, Oxazepam, and Temazepam. Dr. Kunal Saxena, Managing Director of Rusan Pharma, commented, “This USFDA GMP approval underscores our relentless commitment to quality and manufacturing excellence. It enhances our global credibility and reassures our partners of our dedication to producing high-quality APIs that meet the most stringent global standards.“
Enhancing Manufacturing Excellence and Global Reach
The approval of the Ankleshwar facility is a pivotal development in Rusan Pharma’s strategy to become a major player in the global pharmaceutical industry. The company already supplies APIs to numerous US-based firms focusing on orphan drugs, addiction treatment, and obesity medications. This approval will expand Rusan’s capabilities and API product range as well as strengthen its presence in the growing US pharmaceutical market. The Ankleshwar plant has also achieved GMP approval from other international agencies such as Health Canada, the European Union (EU), and ANVISA (Brazil), thanks to the implementation of 21-CFR-compliant software solutions and a move towards paperless manufacturing.
Future Expansion and Vision for Excellence
Prior to this approval, Rusan Pharma had established a strong presence in key markets, including Australia, Brazil, Canada, the EU, Mexico, New Zealand, and the United Kingdom. The USFDA endorsement allows the company to market its APIs to US clients with existing marketing authorizations and those developing new formulations, bolstering trust and confidence globally. Dr. Kunal Saxena emphasized, “Our vision is to be a one-stop solution provider in addiction treatment and pain management. Integration with API production keeps us competitive and independent in supplying critical APIs for manufacturing various finished formulations, particularly narcotic and psychotropic products.”
In November 2023, Rusan Pharma inaugurated a second API manufacturing facility in Pithampur SEZ, Madhya Pradesh, with an annual production capacity of up to 400 MT, surpassing that of the Ankleshwar plant. By mid-2025, the company aims to seek GMP inspection for this new facility by the USFDA and other international agencies, further enhancing its manufacturing capabilities and global reach.
