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18 February, 2019 01:44 IST
Alembic Pharma gets USFDA nod for Candesartan Cilexetil tablets
Source: IRIS | 05 Dec, 2018, 01.05PM
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Alembic Pharmaceuticals today announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Atacand Tablets, 4 mg, 8 mg, and 16 mg, of ANI Pharmaceuticals, Irie. Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Candesartan cilexetil tablets also indicated for the treatment of heart failure.

Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg, hzve an estimated market size of USD 22 million for twelve months ending December 2017 according to IQVIA. Alembic has a cumulative total of 82 ANDA approvals (69 final approvals and 13 tentative approvals) from USFDA.

Shares of the company gained Rs 9.1, or 1.48%, to trade at Rs 624.15. The total volume of shares traded was 3,156 at the BSE (12.56 p.m., Wednesday).



Alembic Pharmaceuticals Limited   (Q,N,C,F)*

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