Alembic Pharmaceuticals gets USFDA final approval for Prazosin Hydrochloride Capsules

Alembic Pharmaceuticals Limited (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. 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.

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

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 525.65 as compared to the previous close of Rs. 501.55. The total number of shares traded during the day was 6188 in over 466 trades.

The stock hit an intraday high of Rs. 528.45 and intraday low of 507.70. The net turnover during the day was Rs. 3219946.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA ANDA FinalApproval PrazosinHydrochlorideCapsules