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Alembic Pharmaceuticals has received approval from the US health regulator for Candesartan Cilexetil tablets which is used for the treatment of hypertension.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Candesartan Cilexetil tablets USP in the strengths of 4 mg, 8 mg, and 16 mg, Alembic Pharmaceuticals said in a filing to BSE today.
The approved product is therapeutically equivalent to the reference listed drug product, Atacand tablets of ANI Pharmaceuticals. Quoting IQVIA data, Alembic Pharma said Candesartan Cilexetil tablets have an estimated market size of $22 million for 12 months ended December 2017.
The company has 82 ANDA approvals from USFDA. Shares of Alembic Pharmaceuticals were trading 1.33 per cent up at Rs 623.25 apiece on the BSE.
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