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是一家专注于成瘾治疗和疼痛管理的全球领先制药公司，它宣布了其位于坎德拉经济特区（SEZ）II单元（印度古吉拉特邦）（“KDL-2”）的最先进的专用高速透皮贴剂和口服薄膜制造设施的两个重要里程碑。

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..

该设施最近获得了澳大利亚治疗用品管理局（TGA）的良好生产规范（GMP）批准，以及巴西卫生管理局（ANVISA）的GMP扩展。。

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..

TGA的批准标志着Rusan Pharma向澳大利亚市场扩张的关键一步。在今年早些时候进行了严格的现场检查后，GMP认证涵盖了透皮贴剂的生产。这些先进的药物输送系统解决了疼痛管理和成瘾治疗中的关键医疗需求，为以患者为中心的治疗方案树立了新的基准。。

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.

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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.

通过获得该认证，我们有能力将我们的专业配方（包括丁丙诺啡，尼古丁透皮贴剂和丁丙诺啡+纳洛酮舌下贴膜）引入澳大利亚市场。这一成就反映了我们致力于创新、提高质量，并通过先进的制药解决方案加强患者护理。”博士。

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..

Saxena还强调，这一GMP批准不仅有助于Rusan Pharma进入澳大利亚，而且符合该公司更广泛的使命，即加强其技术驱动的利基成品配方的全球出口能力。。

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.

同时，ANVISA GMP批准扩展了我们的透皮贴剂设施，加强了我们在快速增长的巴西制药市场中的强大地位。这一里程碑使该公司能够扩大其在巴西的产品组合，提供丁丙诺啡、多奈哌齐、洛索洛芬、利多卡因、双氯芬酸、罗替戈汀、卡巴拉汀和尼古丁贴剂。

“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.

“随着我们的活性药物成分（API）设施获得ANVISA GMP批准，我们的CRO-Quantys Clinical Pvt Ltd（QCPL）获得GCP批准，现在坎德拉II单元透皮贴剂和口服贴剂设施的GMP状态成功扩展，Rusan已成为寻求为巴西或拉丁美洲国家许可我们的利基透皮贴剂和口服贴剂的公司的一站式解决方案提供商。这一里程碑强调了我们持续致力于为巴西各地的患者提供高质量医疗保健解决方案”Dr。

Saxena..

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..

这些TGA和ANVISA GMP批准的双重成就突显了Rusan Pharma的战略重点是扩大其全球足迹，同时保持监管合规性和创新的卓越性。随着公司不断加强其出口能力，这些认证证实了Rusan Pharma成为值得信赖的全球医疗保健合作伙伴的愿景，提供了提高患者预后和生活质量的尖端解决方案。。