Rusan Pharma Secures PMDA Japan GMP Approval for API and Injectable Manufacturing Facilities
Key Insights
Rusan Pharma (search) achieved Good Manufacturing Practice approval from Japan's Pharmaceuticals and Medical Devices Agency (search) for both its API facility in Ankleshwar and injectable manufacturing line in Dehradun.
The approval places Rusan among the few companies worldwide to have both API and finished dosage formulation facilities GMP-approved by Japan's stringent regulatory authority.
This regulatory milestone enhances Rusan's ability to serve highly regulated markets and strengthens its position as a global pharmaceutical manufacturing partner.
Rusan Pharma (search), a pharmaceutical company specializing in pain management (search), movement disorders (search), and addiction (search) solutions, has secured Good Manufacturing Practice (GMP) approval from Japan's Pharmaceuticals and Medical Devices Agency (search) (PMDA) for two key manufacturing facilities. The approval, announced on April 20th, 2026, covers the company's Active Pharmaceutical Ingredient facility in Ankleshwar, Gujarat, and its Small Volume Parenterals (Ampoules) Finished Dosage Formulation manufacturing line in Dehradun, Uttarakhand.
Regulatory Achievement Places Rusan Among Elite Companies
The PMDA approval represents a significant regulatory milestone, as Japan's pharmaceutical authority is recognized as one of the most stringent regulatory bodies globally. According to Dr. Kunal Saxena, Managing Director of Rusan Pharma (search), this achievement places the company "among the very few companies worldwide to have both API and FDF facilities GMP-approved by the Japanese authority."
Dr. Saxena emphasized the significance of the approval, stating: "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."
Expanding Global Manufacturing Capabilities
The PMDA approval enhances Rusan Pharma (search)'s ability to serve highly regulated markets, particularly Japan, while expanding its portfolio of high-quality pharmaceutical offerings. This regulatory milestone marks a significant step in the company's global growth strategy and manufacturing excellence initiatives.
Rusan Pharma (search)'s manufacturing infrastructure spans multiple facilities, with the newly approved sites adding to its global regulatory portfolio. The company's API facility in Ankleshwar and the injectable manufacturing line in Dehradun now join Rusan's network of internationally certified manufacturing sites.
Company's Specialized Focus Areas
Rusan Pharma (search) operates as an integrated global pharmaceutical company with particular expertise in addiction (search) treatment and pain management (search). The company develops, manufactures, and markets specialized APIs and finished formulations, with a focus on novel drug delivery systems including transdermal patches, implants, and depot injections.
The company holds the distinction of being one of the few notified companies authorized to import Narcotic Raw Materials such as Thebaine (search), Oripavine (search), Codeine, and Morphine for manufacturing various APIs and finished formulations in India for both domestic use and global export.
Comprehensive Global Regulatory Portfolio
Beyond the recent PMDA approval, Rusan Pharma (search)'s manufacturing facilities maintain GMP accreditations from multiple international regulatory authorities, including the USFDA, Health Canada, EU, TGA (Australia), SAHPRA (South Africa), Russia, PIC/S (Ukraine), ANVISA (Brazil), and UAE, among others.
The company supplies pharmaceutical products to various international markets including India, Canada, Europe, UK, Russia, CIS countries, South Africa, and other South-East Asian countries. Rusan continues to invest in strengthening its manufacturing infrastructure, quality systems, and regulatory preparedness as part of its long-term vision to serve as a trusted global partner in pharmaceutical manufacturing and healthcare delivery.