Zim Laboratories gets CDSCO nod for Naproxen-Esomeprazole combination capsule

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Zim Laboratories announced that it has received approval from the Central Drugs Standard Control Organization (CDSCO) for its novel fixed-dose combination (FDC) of Naproxen Delayed Release and Esomeprazole capsules (375 mg/500 mg + 20 mg/20 mg).

The formulation has been developed using the companys proprietary drug delivery technologies, combining naproxen delayed-release minitablets and esomeprazole pellets in a single hard gelatin capsule. Zim said the platform offers a differentiated, patient-friendly delivery system and forms part of its New Innovative Product (NIP) pipeline.

The FDC is indicated for adults for the symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for reducing the risk of NSAID-associated gastric and duodenal ulcers.

Zim Laboratories stated that the approval strengthens its presence in the pain-management and gastro-protective segments. The company has already signed a commercial supply agreement with an Indian pharmaceutical firm and is working toward launching the product in India in FY 202627 (FY27). Zim added that the approval aligns with its strategy of developing innovative, differentiated generics using advanced formulation technologies.

ZIM Laboratories is a research-driven pharmaceutical company that develops, manufactures, and supplies differentiated generic products in oral solid dosage forms across key therapeutic segments.

The company's consolidated net profit dropped 117.6% to Rs 0.42 crore as revenue fell 3.7% to Rs 88.71 crore in the quarter ended September 2025 as compared with the previous quarter ended September 2024.

The scrip rose 0.45% to Rs 71.15 on the BSE.

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