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Alembic Pharmaceuticals receives USFDA approval for Prazosin Hydrochloride Capsules

Capital Market 

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Prazosin Hydrochloride Capsules USP, 1 mg, 2 mg, and 5 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Minipress Capsules, 1 mg, 2 mg, and 5 mg, of Pfizer Inc. Prazosin Hydrochloride Capsule 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 US$ 50 million for twelve months ending Dec 2022 according to IQVIA.

Alembic has a cumulative total of 183 ANDA approvals (160 final approvals and 23 tentative approvals) from USFDA.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)


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First Published: Wed, March 08 2023. 09:14 IST
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