Zim Laboratories Receives CDSCO Approval for Naproxen FDC
Filing Summary
Zim Laboratories Limited has obtained approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture and market a Fixed Dose Combination (FDC) of Naproxen Delayed Release and Esomeprazole capsules. The product, developed using Zim’s proprietary drug delivery systems, is intended for the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, while also reducing the risk of NSAID-associated gastric and duodenal ulcers. Zim has signed a commercial supply agreement with an Indian pharmaceutical company and plans to launch the product in India in FY 2026-27.
Zim Laboratories Limited has received approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture and market a Fixed Dose Combination (FDC) of Naproxen Delayed Release and Esomeprazole capsules. The approval was granted on December 3, 2025. The product is formulated with Naproxen Delayed-Release Minitablets and Esomeprazole Pellets, encapsulated in a single hard gelatin capsule.
The FDC is indicated for the symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults. It also aims to reduce the risk of NSAID-associated gastric and duodenal ulcers. The product is part of Zim’s New Innovative Product (NIP) pipeline and utilizes the company’s proprietary drug delivery systems.
Zim Laboratories has entered into a commercial supply agreement with an Indian pharmaceutical company for this product. The company is preparing for the commercial launch of the product in India during the fiscal year 2026-27.
Zim Laboratories Limited 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 focuses on offering innovative drug delivery solutions using proprietary technology platforms to enhance patient convenience and treatment adherence. Zim Laboratories is listed on the National Stock Exchange of India Limited (NSE) and Bombay Stock Exchange (BSE) Limited.