Rusan Pharma Achieves Global GMP Milestone with PMDA Japan Approval

Rusan Pharma’s facilities in Ankleshwar (Gujarat) and Dehradun (Uttarakhand) have successfully secured GMP approval from the PMDA, Japan, one of the most stringent regulatory authorities globally. The approval covers the company’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, said, “I am extremely happy and proud to share that Rusan has been granted GMP approval from one of the world's toughest 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 places Rusan among the very few companies worldwide to have both API and FDF facilities GMP-approved by the Japanese authority, further strengthening our position as a trusted partner for high-quality pharmaceutical development, manufacturing and licensing partner. It reflects the dedication of our teams, the robustness of our systems, and our unwavering focus on delivering world-class quality to patients and partners across the globe.”

This milestone marks a significant step in Rusan Pharma’s global growth journey, enhancing its ability to cater to highly regulated markets such as Japan while expanding its portfolio of high-quality pharmaceutical offerings.

Rusan Pharma continues to invest in strengthening its manufacturing infrastructure, quality systems, and regulatory preparedness, driven by a long-term vision to be a trusted global partner in pharmaceutical manufacturing and healthcare delivery.

About Rusan Pharma:

Rusan Pharma Pvt Ltd. is an integrated global pharmaceutical company and market leader that specialises in the treatment of Addiction and Pain Management. They offer a complete range of super-specialised products in India and globally. Rusan indigenously develops, manufactures, and markets novel APIs and finished formulations and is one of the few notified companies, which is allowed imports of Narcotic Raw Materials (NRM) such as Thebaine, Oripavine, Codeine and Morphine for the purpose of manufacturing various APIs and finished formulation in India and then re-exporting to global markets. Over the years, Rusan has closely worked with Indian and global institutions such as NACO, UNODC, UNOPS, Global Fund, and Ministries of Health to launch Opioid Substitution Therapy in various emerging markets.

Rusan Pharma’s strength lies in innovation of New Drug Delivery Systems (NDDS) such as transdermal patches, implants, depot injections. Rusan was the first company to launch Fentanyl, Buprenorphine and Nicotine Transdermal Patches in India. The company supplies range of products to countries such as India, Canada, Europe, UK, Russia, CIS, South Africa and other South-East Asian countries. Rusan’s API and finished formulation manufacturing facilities hold GMP accreditations such as USFDA, Health Canada, EU, TGA (Australia), SAHPRA (S.Africa), RUSSIA, PIC/S (UKRAINE), ANVISA (Brazil) UAE and many more.