Rusan Pharma Gujarat Plant Receives GMP certification from Australia; Gets extension from Brazil
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...
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 facility, reinforcing Rusan’s commitment to quality and innovation.
Simultaneously, the GMP extension from ANVISA strengthens Rusan Pharma’s presence in the Brazilian pharmaceutical market. This approval enables the company to expand its product portfolio in Brazil with offerings such as Buprenorphine, Donepezil, Loxoprofen, Lidocaine, Diclofenac, Rotigotine, Rivastigmine, and Nicotine patches. The extension complements previous ANVISA approvals for Rusan’s Active Pharmaceutical Ingredient (API) facility and its clinical research organization, Quantys Clinical Pvt Ltd (QCPL), positioning the company as a comprehensive solution provider for transdermal patches and oral films across Brazil and Latin America.
Dr. Kunal Saxena, Managing Director of Rusan Pharma, emphasized that these dual certifications reflect the company’s strategic focus on global expansion through regulatory excellence. He noted that the approvals not only facilitate market entry into Australia and Brazil but also align with Rusan’s broader mission to enhance its export capabilities and deliver high-quality, technology-driven healthcare solutions worldwide.
These achievements underscore Rusan Pharma’s dedication to innovation, regulatory compliance, and improving patient outcomes. As the company continues to grow its international footprint, the TGA and ANVISA certifications serve as a testament to its role as a trusted global healthcare partner.
