Nagpur-based ZIM Laboratories Limited has secured a key European breakthrough.
The company has announced that it has received Marketing Authorization in Italy for its anticoagulant product, Dabigatran Etexilate capsules (75 mg, 110 mg and 150 mg).
This marks a significant step in the company's global expansion strategy.
The approval was granted by Agenzia Italiana del Farmaco (AIFA), clearing the way for the product’s introduction into the Italian market via the Decentralised Procedure (DCP) through ZIM’s wholly owned European subsidiary, SIA ZIM Laboratories Limited, Latvia.
ZIM said the authorization is more than a single-market win—it creates a regulatory pathway that could accelerate approvals across other European Union countries, the UK, and additional global markets, strengthening its commercial footprint.
The newly approved Dabigatran Etexilate capsules are indicated for the prevention and treatment of thromboembolic disorders, including stroke prevention in patients with non-valvular atrial fibrillation.
The company highlighted that the formulation is built on its proprietary non-tartaric acid-based drug delivery platform, incorporating a novel excipient system, and has demonstrated bioequivalence with the reference innovator product.
The company operates as a research-driven pharmaceutical player focused on differentiated generic oral solid dosage forms, backed by in-house R&D and proprietary technology platforms aimed at improving patient convenience and adherence.
According to IQVIA, the European market for Dabigatran Etexilate was valued at approximately US$ 392.84 million in 2025, with Italy alone accounting for about US$ 60.91 million—underscoring the commercial significance of the approval.
ZIM’s latest regulatory win positions it for deeper penetration in the anticoagulant segment across regulated markets, leveraging Italy as a strategic entry point into broader European commercialization.
