VMPL
Mumbai (Maharashtra) [India], April 20: Rusan Pharma, a number one pharmaceutical firm pioneering ache administration, motion dysfunction, and habit options worldwide, has achieved a major international regulatory milestone with the profitable Good Manufacturing Practice (GMP) approvals from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This achievement reinforces the corporate’s dedication to world-class high quality, compliance, and international manufacturing excellence.
Rusan Pharma’s services in Ankleshwar (Gujarat) and Dehradun (Uttarakhand) have efficiently secured GMP approval from the PMDA, Japan, probably the most stringent regulatory authorities globally. The approval covers the corporate’s Active Pharmaceutical Ingredient (API) facility in Ankleshwar and its Small Volume Parenterals (Ampoules) Finished Dosage Formulation (FDF) manufacturing line in Dehradun.
Commenting on the achievement, Dr. Kunal Saxena, Managing Director, Rusan Pharma, mentioned, ‘I’m extraordinarily blissful and proud to share that Rusan has been granted GMP approval from one of many world’s hardest regulatory authorities – Japan’s PMDA – for our API facility in Ankleshwar, Gujarat, and our Finished Dosage Formulation (FDF) ampoule manufacturing line in Dehradun, Uttarakhand. This achievement locations Rusan among the many only a few firms worldwide to have each API and FDF services GMP-approved by the Japanese authority, additional strengthening our place as a trusted companion for high-quality pharmaceutical improvement, manufacturing and licensing companion. It displays the dedication of our groups, the robustness of our programs, and our unwavering concentrate on delivering world-class high quality to sufferers and companions throughout the globe.’
This milestone marks a major step in Rusan Pharma’s international progress journey, enhancing its capability to cater to extremely regulated markets reminiscent of Japan whereas increasing its portfolio of high-quality pharmaceutical choices.
Rusan Pharma continues to spend money on strengthening its manufacturing infrastructure, high quality programs, and regulatory preparedness, pushed by a long-term imaginative and prescient to be a trusted international companion in pharmaceutical manufacturing and healthcare supply.
About Rusan Pharma:
Rusan Pharma Pvt Ltd. is an built-in international pharmaceutical firm and market chief that specialises within the remedy of Addiction and Pain Management. They supply an entire vary of super-specialised merchandise in India and globally. Rusan indigenously develops, manufactures, and markets novel APIs and completed formulations and is among the few notified firms, which is allowed imports of Narcotic Raw Materials (NRM) reminiscent of Thebaine, Oripavine, Codeine and Morphine for the aim of producing varied APIs and completed formulation in India after which re-exporting to international markets. Over the years, Rusan has carefully labored with Indian and international establishments reminiscent of NACO, UNODC, UNOPS, Global Fund, and Ministries of Health to launch Opioid Substitution Therapy in varied rising markets.
Rusan Pharma’s power lies in innovation of New Drug Delivery Systems (NDDS) reminiscent of transdermal patches, implants, depot injections. Rusan was the primary firm to launch Fentanyl, Buprenorphine and Nicotine Transdermal Patches in India. The firm provides vary of merchandise to international locations reminiscent of India, Canada, Europe, UK, Russia, CIS, South Africa and different South-East Asian international locations. Rusan’s API and completed formulation manufacturing services maintain GMP accreditations reminiscent of USFDA, Health Canada, EU, TGA (Australia), SAHPRA (S.Africa), RUSSIA, PIC/S (UKRAINE), ANVISA (Brazil) UAE and lots of extra.
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