ZIM Laboratories has secured Marketing Authorization 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 via DCP to its wholly owned European subsidiary, SIA ZIM Laboratories, Latvia. This authorisation will facilitate faster approvals in other European Union countries as well as the UK and other markets globally resulting in better commercialisation opportunities.
Dabigatran Etexilate Capsules are indicated for the prevention and treatment of thromboembolic disorders, including stroke prevention in patients with non-valvular atrial fibrillation. The product has been developed using the company’s proprietary non-tartaric acid-based formulation design incorporating a novel excipient system and has demonstrated bioequivalence with the innovator product.
ZIM Laboratories manufactures, formulates, and distributes drug delivery systems to develop generic pharmaceutical products.
