Alembic Pharma Hypertension drug Prazosin Hydrochloride gets USFDA okay

Vadodara: Drugmaker Alembic Pharmaceuticals Limited has announced that the company 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.

PrazosinHydrochloride Capsule is indicated for the treatment of hypertension, to lower blood pressure.

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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. 

Medical Dialogues team had earlier reported that the company had received final approval from the USFDA for its ANDA Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg, and 90 mg. Nifedipine Extended-Release Tablets are indicated for the management of i) Vasospastic Angina ii) Chronic Stable Angina (Classical EffortAssociated Angina) and iii) Hypertension.

Read also: Alembic Pharma bags USFDA nod for Hypertension drug Nifedipine Extended Release

Headquartered in Vadodara, Gujarat, Alembic Pharmaceuticals Limited is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. The company was founded in 1907. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic has a cumulative total of 183 ANDA approvals (160 final approvals and 23 tentative approvals) from USFDA.