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“The tentative approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim,” Alembic Pharma said in press release.
Dabigatran Etexilate Capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep vanous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, the company said.
It is also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated, it added.
According to IMS, Dabigatran Etexilate Capsules, 150 mg have an estimated market size of USD 726.3 million for 12 months ending December 2016.
At 11:23 am; the stock was up 5% at Rs 541 on BSE, as compared to 0.28% rise in the S&P BSE Sensex. A combined 164,760 shares changed hands on the counter on BSE and NSE so far.