Zim Laboratories Gets Marketing Authorization for Dabigatran Etexilate in Italy
Zim Laboratories Limited's European subsidiary received Marketing Authorization from AIFA for Dabigatran Etexilate capsules in Italy. This approval is anticipated to accelerate market entry in other EU countries and globally. The EU market for this product was approximately USD 392.84 million in 2025.
The marketing authorization in Italy for Dabigatran Etexilate is a positive development that could lead to increased revenue and market presence in Europe. The market size figures indicate potential for growth.
The company has received marketing authorization for a key product in a significant European market, which is expected to open up further commercialization opportunities.
Zim Laboratories Limited announced that its wholly-owned European subsidiary, SIA Zim Laboratories Limited, Latvia, has received Marketing Authorization (MA) from Agenzia Italiana del Farmaco (AIFA), the Italian Medicines Agency, for its anticoagulant product "Dabigatran Etexilate" (75 mg, 110 mg & 150 mg hard capsules) in Italy. This authorization was granted via the Decentralised Procedure (DCP).
The approval is expected to expedite approvals in other European Union countries, the UK, and global markets, thereby enhancing commercialization opportunities. Dabigatran Etexilate Capsules are used for preventing and treating thromboembolic disorders, including stroke prevention in patients with non-valvular atrial fibrillation.
The product was developed using Zim Laboratories Limited's proprietary non-tartaric acid-based formulation design with a novel excipient system, demonstrating bioequivalence to the innovator product. The EU market for this product was valued at approximately USD 392.84 million (₹3,273.67 crore) in 2025, with Italy contributing USD 60.91 million (₹507.58 crore).
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