Rusan Pharma has achieved a major global regulatory milestone with Good Manufacturing Practice (GMP) approvals from Pharmaceuticals and Medical Devices Agency (PMDA), reinforcing its capabilities in high-quality pharmaceutical manufacturing.

The approvals cover the company’s Active Pharmaceutical Ingredient (API) facility in Ankleshwar and its Small Volume Parenterals (ampoules) Finished Dosage Formulation (FDF) manufacturing line in Dehradun. PMDA is regarded among the most stringent regulatory bodies globally, making this certification a significant endorsement of Rusan Pharma’s compliance and quality standards.

Commenting on the development, Dr Kunal Saxena, Managing Director, said the approval places Rusan among a select group of companies worldwide to have both API and FDF facilities cleared by Japan’s regulator. He added that the achievement reflects the strength of the company’s systems, operational excellence, and commitment to delivering world-class quality to global partners and patients.

The milestone strengthens Rusan Pharma’s position in regulated markets, particularly Japan, and supports its broader global expansion strategy. It also enhances the company’s ability to offer integrated pharmaceutical development, manufacturing, and licensing solutions.

With continued investments in manufacturing infrastructure, quality systems, and regulatory readiness, Rusan Pharma aims to further expand its footprint as a trusted global partner in specialty pharmaceutical segments such as pain management, addiction therapy, and movement disorders.