Alembic Pharma bags USFDA approval for Candesartan Cilexetil Tablets

Alembic Pharmaceuticals Limited, a R&D focused pharma company, informed that the USFDA has given approval for its Candesartan Cilexetil Tablets USP 4 mg, 8 mg, and 16 mg. The above products come under Abbreviated New Drug Application (ANDA) scheme. The approved ANDA is a therapeutically equivalent to the reference listed drug product (RLD), Atacand Tablets, 4 mg, 8 mg, and 16 mg, of ANI Pharmaceutical.

Candesartan Cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to < 17years of age to lower blood pressure. Candesartan Cilexetil tablets are also indicated for the treatment of heart failure. Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg had an estimated market size of US$ 22 million for 12 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.

Stock reacted positively to the news to touch an intraday high of Rs. 633.74 per share. At 14:40 hours, the stock was trading at Rs. 623.60, higher by 1.39 per cent on BSE. While the benchmark index was trading at 35,895.69, down by 238.62 points or 0.66 per cent.