ZIM Laboratories Limited has announced that it has secured approval from the Central Drugs Standard Control Organization (CDSCO) for its new Fixed Dose Combination (FDC) of Naproxen Delayed Release and Esomeprazole capsules. The regulatory clearance allows the company to manufacture and market the formulation in India.
The approval covers two strengths — 375 mg/20 mg and 500 mg/20 mg — combining delayed-release Naproxen with Esomeprazole in a single hard-gelatin capsule. The product has been developed using ZIM’s proprietary technologies, which include Naproxen delayed-release minitablets and Esomeprazole pellets filled together to enhance patient convenience and treatment adherence.
Why this approval matters
The newly approved FDC is intended for adults requiring symptomatic treatment of conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It also helps reduce the risk of NSAID-associated gastric and duodenal ulcers, making it a dual-benefit therapy for pain relief and gastric protection.
ZIM Laboratories highlighted that the approval strengthens its presence in both pain management and gastro-protective therapeutic categories. The company has already entered into a commercial supply agreement with an Indian pharmaceutical partner and is targeting a market launch in FY 2026–27.
The development aligns with ZIM’s strategy to scale innovative and differentiated generic formulations through advanced drug-delivery platforms — a core focus of its research-driven product pipeline.
