Rusan Pharma secures PMDA GMP approval for Ankleshwar and Dehradun facilities

Rusan Pharma announced that it has received Good Manufacturing Practice approval from the Pharmaceuticals and Medical Devices Agency for its manufacturing facilities in India.

The approval 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.

The company stated that the approval has been granted by the Pharmaceuticals and Medical Devices Agency, Japan, and applies to both API and finished dosage facilities.

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.”

The company stated that the approval supports its plans to serve regulated markets such as Japan and expand its pharmaceutical portfolio.

Rusan Pharma stated that it will continue to invest in manufacturing infrastructure, quality systems, and regulatory processes as part of its global operations.

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