ZIM Laboratories Secures Marketing Authorization for Dabigatran Etexilate in Italy, Expanding European Market Presence

ZIM Laboratories Secures Marketing Authorization for Dabigatran Etexilate in Italy, Expanding European Market Presence​

ZIM Laboratories Limited announced the grant of Marketing Authorization (MA) for its anticoagulant product, Dabigatran Etexilate (75 mg, 110 mg, and 150 mg hard capsules), in Italy and the broader European market.

The Italian Medicines Agency (AIFA) granted the Marketing Authorization for ZIM’s anti-coagulant product. The authorization was issued to SIA ZIM Laboratories Limited, the company's wholly owned European subsidiary based in Latvia.

This significant authorization is expected to facilitate quicker approvals in other European Union countries, as well as other global markets including the UK, thereby creating better commercialization opportunities for ZIM Laboratories Limited.

Dabigatran Etexilate Capsules are clinically indicated for the prevention and treatment of thromboembolic disorders. This includes stroke prevention in patients suffering from non-valvular atrial fibrillation. The product is noted for being developed using ZIM Laboratories Limited's proprietary non-tartaric acid-based formulation design, incorporating a novel excipient system, and has demonstrated bioequivalence with the innovator product.

The successful authorization provides ZIM Laboratories Limited with a strong foothold in key global pharmaceutical markets. Market data for the product in Europe illustrates the potential size of this segment. According to IQVIA, the market size for this product in 2025 was approximately USD 392.84 MN, with Italy contributing a portion of 60.91 MN USD.

ZIMLAB Stock Price Movement​

On Tuesday, Zim Laboratories Limited shares rallied, climbing 4.71% and settling at ₹100.6. The stock recorded a total volume of 45,544 shares during the trading session.