Alembic Pharmaceuticals Limited 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, have an estimated market size of US$ 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 ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.618.1 as compared to the previous close of Rs. 615.05. The total number of shares traded during the day was 5121 in over 330 trades.
The stock hit an intraday high of Rs. 633.7 and intraday low of 614.9. The net turnover during the day was Rs. 3188981.