Alembic Pharma bags USFDA approval for Dabigatran Etexilate capsules, stock surges

Indian pharma major Alembic Pharmaceuticals added yet another USFDA approval to its bag by securing a tentative approval for its abbreviated new drug application (ANDA) to manufacture Dabigatran Etexilate capsules, 150mg.

Dabigatran Etexilate capsules is said to be therapeutically equivalent to a reference listed drug product (RLD) PRADAXA Dabigatran Etexilate Mesylate Capsules, equal to 150 mg base, Boehringer Ingelheim.

Dabigatran Etexilate Capsules lowers the risk of stroke and systemic embolism in patients suffering from non-valvular atrial fibrillation, and is also instrumental 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 drug is also said to reduce the risk of relapse of DVT and PE in patients who have previously suffered from it.

According to various market data, the Dabigatran Etexilate Capsules, 150 mg had an estimated market size of USD 726.3 million for the 12 months ending December 2016.

The company has secured over 60 ANDA approvals from the USFDA. While, the company secured a string of USFDA approvals over the last one month, including the approvals for Amantadine Hydrochloride capsules used for the treatment of symptoms of infection caused by influenza virus, approval for a hypertension drug named Candesartan Cilexetil Tablets 32mg and for the vardenafil hydrochloride tablets used for the treatment of erectile dysfunction. 

The stock of the company surged over 3 per cent to Rs 43.35 on BSE in intraday trade on Tuesday, July 11. In sync with the stock, the S&P BSE Healthcare index was trading at 14566.21, up by 0.13 per cent.