Rusan Pharma achieves dual GMP milestones from TGA, Australia and ANVISA, for its manufacturing facility

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 Ltd, a globally recognized pharmaceutical company specializing in addiction treatment and pain management, has achieved two major regulatory milestones for its advanced manufacturing facility located in the Kandla Special Economic Zone (SEZ)-UNIT-II, Gujarat, India (“KDL-2”).

The facility has received Good Manufacturing Practice (GMP) certification from Australia’s Therapeutic Goods Administration (TGA) and an extended GMP approval from Brazil’s Health Regulatory Agency, ANVISA. These approvals mark a significant step in Rusan’s strategic expansion into key international markets.

The TGA certification follows a comprehensive on-site inspection and covers the production of transdermal patches—innovative drug delivery systems that offer targeted solutions for pain and addiction management. This marks the second successful TGA inspection of the KDL-2 facility, reinforcing Rusan’s commitment to quality and regulatory excellence.

Dr. Kunal Saxena, Managing Director of Rusan Pharma, commented, “We are proud to receive A1 GMP compliance from the TGA for our dedicated transdermal patch and oral film facility. This certification enables us to introduce specialized formulations such as buprenorphine, nicotine patches, and buprenorphine+naloxone sublingual films to the Australian market. It reflects our dedication to innovation and improving patient care.”

In parallel, the extended GMP approval from ANVISA strengthens Rusan’s presence in Brazil, allowing the company to expand its product offerings with formulations including buprenorphine, donepezil, loxoprofen, lidocaine, diclofenac, rotigotine, rivastigmine, and nicotine patches. This milestone supports Rusan’s broader mission to enhance its export capabilities across Latin America.

Dr. Saxena added, “With ANVISA’s GMP extension, along with API facility approvals and GCP certification for our CRO—Quantys Clinical Pvt Ltd (QCPL)—Rusan is now a comprehensive solution provider for companies seeking to in-license niche transdermal and oral film products for Brazil and LATAM markets.”

These dual GMP achievements underscore Rusan Pharma’s strategic focus on global growth, regulatory compliance, and innovation. As the company continues to expand its international footprint, these certifications affirm its vision of being a trusted healthcare partner, delivering high-quality, technology-driven therapies that improve patient outcomes worldwide.

Rusan Pharma is a fully integrated pharmaceutical company, manufacturing and marketing a wide range of APIs and finished formulations, particularly in controlled substances for addiction and pain management.