By: IPP Bureau
Last updated : December 04, 2025 2:40 pm
Grant of Permission to manufacture and market FDC of Naproxen Delayed Release and Esomeprazole capsule (375mg/500mg + 20mg/20mg)
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 our New Innovative Product (NIP) pipeline.
The FDC is indicated in adults for: Symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis Reducing the risk of NSAID-associated gastric and duodenal ulcers
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).