Alembic Pharmaceuticals receives USFDA Approval for Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg.
Deepthi | Myequity news | Date : 05-12-2018 12:00:00 IST
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, hzve an estimated market size of US$ 22 million for twelve months ending December 2017 according to IQVIA.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceuticcl company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.