Rusan Pharma has achieved a significant global regulatory milestone with the successful Good Manufacturing Practice (GMP) approvals from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
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.
