Rusan Product List - 2026

Rusan Pharma Ltd. has achieved two major regulatory milestones for its advanced manufacturing facility located in the Kandla Special Economic Zone (SEZ) Unit-II in Gujarat, India. The facility, which specializes in high-speed production of transdermal patches and oral films, has received Good Manufacturing Practice (GMP) certification from Australia’s Therapeutic Goods Administration (TGA) and a GMP extension from Brazil’s Health Regulatory Agency, ANVISA.

The TGA certification marks a pivotal step in Rusan Pharma’s expansion into the Australian market. Following a rigorous inspection, the facility was granted A1 GMP compliance, validating its capability to produce specialized drug delivery systems such as Buprenorphine, Nicotine Transdermal Patches, and Buprenorphine+Naloxone Sublingual Films. These products are designed to address critical medical needs in pain management and addiction treatment. This is the second time the TGA has approved the Kandla Unit-II faci...

Please find attached our latest API list for 2026

Corporate+ Font Resize -Rusan Pharma achieves dual GMP milestones from TGA, Australia and ANVISA, for its manufacturing facilityOur Bureau, Mumbai
Friday, December 13, 2024, 16:45 Hrs  [IST]Rusan Pharma Ltd, a leading global pharmaceutical company specialising in addiction treatment and pain management, has announced two significant milestones for its state-of-the-art dedicated high-speed transdermal patch and oral film manufacturing facility, located in the Kandla Special Economic Zone (SEZ)-UNIT-II (Gujarat, India) (“KDL-2”). 

RUSAN PHARMA PRIVATE LIMITED, an Indian pharmaceutical company specializing in addiction treatment and pain management, announced that its Active Pharmaceutical Ingredient (API) facility in Ankleshwar, Gujarat, received Good Manufacturing Practice (GMP) approval from the USFDA on May 29, 2024, following a rigorous inspection. This approval marks a significant milestone, enabling Rusan to expand into the US API market, particularly for niche APIs like Eflornithine and Nalmefene, while planning to add more APIs to its portfolio. Rusan Pharma’s Managing Director, Dr. Kunal Saxena, emphasized the company’s commitment to quality and global expansion. The USFDA approval complements Rusan's existing GMP certifications from Health Canada, the EU, and Brazil’s ANVISA, and aligns with the company’s vision to be a leader in addiction treatment and pain management. 

Rusan Corporate presentation