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Monday, December 11, 2023

Alembic Pharma receives USFDA final approval for Prazosin Hydrochloride Capsules


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Mumbai: Pharma major, Alembic Pharma on Wednesday said 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. Refer to our label for full indication.

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.


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