Rusan Pharma has achieved a significant global milestone by receiving Good Manufacturing Practice (GMP) approval from Pharmaceuticals and Medical Devices Agency (PMDA), one of the world’s most stringent drug regulators.
The approval covers the company’s Active Pharmaceutical Ingredient (API) facility in Ankleshwar, Gujarat, and its finished dosage formulation ampoule manufacturing line in Dehradun, Uttarakhand. This certification confirms that both facilities meet Japan’s high standards for quality compliance and safety.
With this achievement, Rusan Pharma becomes one of the few companies globally to secure Japan PMDA approval for both API and formulation units. It reflects the company’s strong focus on pharmaceutical manufacturing standards and international regulatory requirements.
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Managing Director Kunal Saxena said the approval highlights the company’s commitment to delivering reliable and high-quality pharmaceutical products. He added that it also strengthens Rusan Pharma’s position in the global pharmaceutical market.
The PMDA nod is expected to open new opportunities in regulated markets such as Japan and support the company’s export growth strategy. It also reinforces its capabilities in drug development and manufacturing.
Rusan Pharma is known for its expertise in pain management, addiction treatment, and neurological care, with continued investments in healthcare manufacturing excellence and compliance systems.
Industry experts believe such approvals enhance India’s standing in the pharmaceutical exports sector and strengthen its image as a reliable supplier of quality medicines.
Going forward, the company aims to expand its portfolio and maintain strong adherence to global quality standards, further cementing its international presence.
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