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ZIM Laboratories gets CDSCO’s approval for Naproxen plus Esomeprazole Capsules
Dec-03-2025

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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