Alembic Pharmaceuticals Limited on Wednesday announced that it has received final approval from the US health regulatory, USFDA, for its abbreviated new drug application of Prazosin Hydrochloride Capsules, which is used for treatment of hypertension. “The approved ANDA (abbreviated new drug application) is therapeutically equivalent to the reference listed drug product (RLD), Minipress Capsules, 1 mg, 2 mg, and 5 mg, of Pfizer Inc,” the company said in a release posted on stock exchanges.
Prazosin Hydrochloride Capsule, it said, is indicated for the treatment of hypertension, to lower blood pressure.
Prazosin Hydrochloride Capsules USP, 1 mg, 2 mg, and 5 mg have an estimated market size of USD 50 million for 12 months ended December 2022, according to IQVIA.
Alembic has a cumulative total of 183 ANDA approvals (160 final approvals and 23 tentative approvals) from the US Food & Drug Administration (USFDA).
Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. It is one of the leaders in branded generics in India.