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Vadodara-based drug player Alembic Pharmaceuticals Ltd has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Telmisartan and Amlodipine Tablets.
In a statement, the company said the USFDA has granted approval for its ANDA for Telmisartan and Amlodipine Tablets in the strengths of 40 mg/5mg, 40mg/10 mg, 80 mg/5 mg and 80 mg/ 10 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD) product Twynsta Tablets of Boehringer Ingelheim Pharmaceuticals Inc. Twynsta tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents to reduce blood pressure, it stated.
Alembic now has a total of 50 ANDA approvals (44 final approvals and 6 tentative approvals) from USFDA.
On Friday, company shares closed at Rs 606 on the National Stock Exchange (NSE) with loss of 0.59 per cent from its previous close.
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