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Ankleshwar, India – July 22, 2024 – RUSAN PHARMA PRIVATE LIMITED, a pharmaceutical company based in India specializing in the area of 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, India). 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 as it paves the way for it to enter 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, highlights, "This GMP approval by the USFDA 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 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.
Following on-site audits, Rusan’s API facility in Ankleshwar is 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 & 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, 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 our customers' and regulatory agencies' trust and confidence in us 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 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" adds 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.
In November 2023, Rusan Pharma inaugurated its second API manufacturing facility in Pithampur SEZ (Madhya Pradesh, India) with an annual production capacity of upto 400 MT, which is significantly higher than the Ankleshwar plant. By mid-2025, the company plans to seek GMP inspection of this new facility by the USFDA and other international inspecting agencies. This expansion aims to boost Rusan's manufacturing capabilities.
About Rusan Pharma Pvt Ltd:
Rusan Pharma Pvt Ltd. is an integrated global pharmaceutical company and market leader that specializes in the treatment of Addiction and Pain Management. They offer a complete range of super-specialized products in India and globally. Rusan indigenously develops, manufactures, and markets novel APIs and finished formulations and is one of the few notified companies, which is allowed imports of Narcotic Raw Materials (NRM) such as Thebaine, Oripavine, Codeine and Morphine for the purpose of manufacturing various APIs and finished formulation in India and then re-exporting to global markets. Over the years, Rusan has closely worked with Indian and global institutions such as NACO, UNODC, UNOPS, Global Fund, and Ministries of Health to launch Opioid Substitution Therapy in various emerging markets.
Rusan Pharma’s strength lies in innovation of New Drug Delivery Systems (NDDS) such as transdermal patches, implants, depot injections. Rusan was the first company to launch Fentanyl, Buprenorphine and Nicotine Transdermal Patches in India. The company supplies range of products to countries such as India, Canada, Europe, UK, Russia, CIS, South Africa and other South-East Asian countries. Rusan’s API and finished formulation manufacturing facilities hold GMP accreditations such as USFDA, Health Canada, EU, TGA (Australia), SAHPRA (S.Africa), RUSSIA, PIC/S (UKRAINE), ANVISA (Brazil) UAE and many more.
