Rusan Pharma API Ankleshwar plant gets USFDA GMP nod

"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," the Company stated.

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.”

According to the release, 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. 

Before receiving this approval, Rusan Pharma established a 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.

"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.

Read also: Rusan Pharma launches State-of-the-Art facility for APIs in Pithampur