ZIMLABBSEZim Laboratories LtdMediumPositive
Announced Tue, 19 May · 18:11 IST

Please find attached a press release dated 19th May 2026 titled "ZIM Laboratories Limited announces grant of Marketing Authorization (MA) for Dabigatran Etexilate (75 mg, 110 mg &150 mg) ....

Regulatory Product ApprovalExport Order Hard CurrencyBusiness Updates View source PDF

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▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.

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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. This anticoagulant product is used for preventing and treating thromboembolic disorders including stroke prevention in atrial fibrillation patients. The EU market for this product was approximately USD 392.84 million in 2025, with Italy accounting for USD 60.91 million. The authorization was obtained via the DCP (Decentralised Procedure), which enables faster approvals across other EU member states and the UK. The product uses ZIM's proprietary non-tartaric acid-based formulation and has demonstrated bioequivalence with the innovator.

Likely market impact

This approval opens up a significant European market opportunity for ZIM, with the authorization serving as a gateway to broader EU market access, potentially driving export revenue in hard currencies (EUR/GBP).