ZIM Laboratories gets CDSCO’s approval for Naproxen plus Esomeprazole Capsules

03 Dec 2025 Evaluate

ZIM Laboratories has received permission from the Indian Central Drugs Standard Control Organization (CDSCO) for its novel Fixed Dose Combination formulation: Naproxen Delayed Release and Esomeprazole Capsules (375 mg/500 mg + 20 mg/20 mg). This product has been developed using ZIM’s proprietary drug delivery systems, comprising Naproxen Delayed-Release Minitablets, and Esomeprazole Pellets, filled together in a single hard gelatin capsule offering a differentiated and patient-friendly delivery platform and is part of its New Innovative Product (NIP) pipeline. 

This approval strengthens ZIM’s presence in the pain management and gastro-protective therapeutic areas. ZIM has already signed a commercial supply agreement with an Indian pharmaceutical company for this product and is working toward commercial launch in India in FY 2026-27 (FY27). The approval also reinforces ZIM’s strategy of developing innovative, differentiated generics leveraging advanced formulation technologies.

ZIM Laboratories manufactures, formulates, and distributes drug delivery systems to develop generic pharmaceutical products.


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