Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ

Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ

The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market

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).

This facility recently received Good Manufacturing Practice (GMP) approval from Australia’s Therapeutic Goods Administration (TGA) and a GMP extension from the Brazilian Health Regulatory Agency – ANVISA.

The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market. Following a rigorous on-site inspection earlier this year, the GMP certification encompasses the manufacturing of transdermal patches. These advanced drug delivery systems address critical medical needs in pain management and addiction treatment, setting a new benchmark for patient-focused therapeutic solutions.

Commenting on this achievement, Dr. Kunal Saxena, Managing Director of Rusan Pharma Ltd., said, “We are delighted that our dedicated transdermal patch and oral film manufacturing facility in Kandla SEZ (Unit II), Gujarat, has received A1 GMP compliance certification from the TGA, Australia. This is the second time the TGA has inspected and approved Rusan’s Kandla Unit-II facility. By achieving this certification, we are well-positioned to introduce our specialized formulations, including Buprenorphine, Nicotine Transdermal Patches, and Buprenorphine+Naloxone Sublingual Films, to the Australian market. This accomplishment reflects our commitment to innovation, quality, and enhancing patient care through advanced pharmaceutical solutions.” Dr. Saxena also emphasised that this GMP clearance not only facilitates Rusan Pharma’s entry into Australia but also aligns with the company’s broader mission to strengthen its global export capabilities of technology-driven niche finished formulations.

Simultaneously, the ANVISA GMP approval extension our transdermal patch facility, reinforcesour strong position in the rapidly growing Brazilian pharmaceutical market. This milestone enables the company to expand its product portfolio in Brazil with offerings such as Buprenorphine, Donepezil, Loxoprofen, Lidocaine, Diclofenac, Rotigotine, Rivastigmine, and Nicotine patches. “With the ANVISA GMP approvals of our Active Pharmaceutical Ingredient (API) facility, GCP approval of our CRO – Quantys Clinical Pvt Ltd (QCPL) and now the successful extension of the GMP status of the Kandla Unit-II facility for transdermal patches and oral films, Rusan has become a one-stop-solution provider for companies who are looking for in-licensing our niche transdermal patches and oral films for the Brazilian or the LATAM countries.This milestone underscores our ongoing commitment to delivering high-quality healthcare solutions to patients across Brazil” adds Dr. Saxena.

These dual achievements—TGA and ANVISA GMP approvals—underscore Rusan Pharma’s strategic focus on expanding its global footprint while maintaining excellence in regulatory compliance and innovation. As the company continues strengthening its export capabilities, these certifications affirm Rusan Pharma’s vision of being a trusted global healthcare partner, delivering cutting-edge solutions that enhance patient outcomes and quality of life.