ZIMLABNSEZim Laboratories LimitedHighPositive
Announced Tue, 19 May · 18:03 IST

Zim Laboratories Limited has informed the Exchange regarding a press release dated May 19, 2026, titled "ZIM Laboratories Limited Announces Grant of Marketing Authorization (MA) for Dabigatran Etexilate (75 mg, 110 mg & 150 mg) Capsules inItaly, Europe".

Regulatory Product ApprovalExport Order Hard CurrencyBusiness Updates View source PDF

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AI summary

Zim Laboratories Limited's wholly owned European subsidiary (SIA ZIM Laboratories Limited, Latvia) has received Marketing Authorization from AIFA (Italian Medicines Agency) for Dabigatran Etexilate capsules in three dosage strengths (75mg, 110mg, 150mg). The product is an anticoagulant used for preventing and treating thromboembolic disorders including stroke prevention in patients with non-valvular atrial fibrillation. According to IQVIA, the EU market size for this product was approximately USD 392.84 million in 2025, with Italy contributing USD 60.91 million. This authorization facilitates faster approvals in other EU countries as well as the UK and other global markets.

Likely market impact

This regulatory approval opens significant commercial opportunities for ZIM Laboratories in the European market, leveraging their proprietary non-tartaric acid-based formulation. The company can now expand revenue streams from the large EU anticoagulant market.