Rusan Pharma’s API Facility In Ankleshwar Gains USFDA GMP Approval

Rusan Pharma, an Indian pharmaceutical company specialising in addiction treatment and pain management, in a press statement on Tuesday, informed 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 (US FDA). 

The approval, granted on May 29, 2024, followed an extensive five-day inspection from April 29 to May 3, 2024, the statement from the company stated.

This significant milestone enables Rusan Pharma to enter the US API market. The company currently holds an active US Drug Master File (DMF) for niche APIs such as 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.

Kunal Saxena, Managing Director of Rusan Pharma, stated, "This GMP approval by the US FDA underscores our unwavering commitment to maintaining the highest standards of quality and manufacturing excellence, expanding our global presence and credibility. This achievement instills 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 US FDA approval of the Ankleshwar facility is a pivotal development in Rusan Pharma's strategy to become a key player in the global pharmaceutical industry. The company supplies APIs to various US-based companies focused on orphan drugs, addiction treatment, and obesity medications. This 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 international agencies, including Health Canada, the European Union (EU), and ANVISA (Brazil). The company has implemented 21-CFR-compliant software solutions such as SAP, Laboratory Information Management System (LIMS), document & quality management systems (DMS & QMS), and electronic logbooks, ensuring a move towards paperless manufacturing. Comprehensive staff training and monitoring were integral to overcoming the challenges posed by this transition.

Before receiving this approval, Rusan Pharma had already 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 enables the company to market its APIs to US clients with existing marketing authorisations and those developing new formulations. This approval further bolsters trust and confidence in Rusan from customers and regulatory agencies 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 formulation 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. Hence, a robust supply of API enables us to achieve a rapid time to market with critical products," added Kunal Saxena.

Rusan’s Ankleshwar manufacturing unit plays a strategic role in its manufacturing and distribution network, focusing on critical APIs like fentanyl and buprenorphine. The company aims to be a comprehensive provider of addiction treatment and pain management solutions, ensuring competitive and timely delivery of quality medicines.

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, significantly higher than the Ankleshwar plant. By mid-2025, the company plans to seek GMP inspection of this new facility by the US FDA and other international inspecting agencies, aiming to boost Rusan's manufacturing capabilities, the press statement added.