Rusan Pharma, a global leader in addiction treatment and pain management, has achieved two significant milestones that further solidify its position in the pharmaceutical industry. The company’s advanced transdermal patch and oral film manufacturing facility in Kandla Special Economic Zone (SEZ)-Unit II, Gujarat, has received Good Manufacturing Practice (GMP) approval from Australia's Therapeutic Goods Administration (TGA) and a GMP extension from Brazil's health regulator, ANVISA.

The TGA certification is a pivotal development, enabling Rusan Pharma to expand its reach into the Australian market. After a stringent on-site inspection earlier this year, the certification endorses the facility’s production of transdermal patches—innovative drug delivery systems designed for pain management and addiction treatment. These products promise enhanced therapeutic efficacy and patient comfort, setting new standards in patient care.

Dr. Kunal Saxena, Managing Director of Rusan Pharma Ltd., expressed his pride in the accomplishment, stating, “We are delighted that our Kandla SEZ (Unit II) facility has achieved A1 GMP compliance certification from TGA, Australia. This is the second time our facility has been approved by TGA, reflecting our dedication to quality and innovation. With this certification, we are prepared to introduce our specialized formulations, such as Buprenorphine and Nicotine Transdermal Patches, to the Australian market.” Dr. Saxena emphasized that this milestone aligns with Rusan Pharma's mission to expand its global export capabilities while driving innovation in pharmaceutical solutions.

Simultaneously, the ANVISA GMP approval extension marks another leap forward for Rusan Pharma in the Brazilian market. The company’s expanded portfolio will now include transdermal patches for products like Buprenorphine, Donepezil, Lidocaine, Diclofenac, Rotigotine, and Nicotine, addressing a wide range of medical needs in Brazil. Dr. Saxena highlighted this achievement, adding, “With the ANVISA approval, Rusan Pharma is positioned as a one-stop solution for companies seeking to in-license our transdermal patches and oral films across Brazil and other LATAM countries. This milestone reinforces our commitment to delivering high-quality healthcare solutions to patients globally.”

These dual approvals underscore Rusan Pharma’s strategic focus on expanding its global footprint while maintaining excellence in innovation and regulatory compliance. With advanced manufacturing capabilities and a robust export strategy, the company continues to position itself as a trusted global healthcare partner dedicated to improving patient outcomes and quality of life.