ZIM Laboratories Ltd receives approval from CDSCO - Directorate General of Health Services for Naproxen + Esomeprazole Capsules

Grant of Permission to manufacture and market FDC of Naproxen Delayed Release and Esomeprazole capsule (375mg/500mg + 20mg/20mg)

ZIM Laboratories Limited (the Company) 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 has state-of-the-art in-house R&D capabilities to offer innovative drug delivery solutions using proprietary technology platforms, aiming to enhance patient convenience and treatment adherence. ZIM Laboratories Limited is listed on the National Stock Exchange of India Limited (NSE) and Bombay Stock Exchange (BSE) Limited.

The company is pleased to announce that it 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.

Therapeutic Indication

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

Strategic Significance

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.

Shares of Zim Laboratories Ltd was last trading in BSE at Rs. 71.47 as compared to the previous close of Rs. 73.17. The total number of shares traded during the day was 672 in over 43 trades.

The stock hit an intraday high of Rs. 72.61 and intraday low of 71.20. The net turnover during the day was Rs. 48165.00.

Source : Equity Bulls

Keywords

ZimLaboratories INE518E01015 Pharmaceuticals CDSCO Approval NovelFixedDoseCombination Naproxen Esomeprazole Capsules