Alembic Pharmaceuticals Ltd. 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.

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An Abbreviated New Drug Application (ANDA) contains data, which is submitted to the FDA for review and potential approval of a generic drug product.

The approved drug is the therapeutic equivalent to the reference listed drug product - Minipress Capsules, 1 mg, 2 mg and 5 mg, of Pfizer Inc.

Prazosin Hydrochloride Capsules are used in the treatment of hypertension and lower blood pressure.

The drugs had an estimated market size of $50 million for the 12-month period that ended in December 2022, according to the IQVIA data.

As of date, Alembic Pharma has a total of 183 ANDA approvals, which includes 160 final approvals and 23 tentative ones.

Shares of Alembic Pharma had recovered from a 52-week low on Monday after the company had received final approval from the US drug regulator for a colon cancer injection. The Fluorouracil Injection has an estimated market size of $5 million for twelve months ending December 2022 according to IQVIA.

Last week, the Vadodara-based drugmaker announced that it will be taking an impairment charge of Rs 1,150.43 crore pertaining to its three under-construction manufacturing plants in Gujarat.

Shares of Alembic Pharmaceuticals are trading 0.7 percent lower at Rs 521.85.

First Published:Mar 8, 2023 10:33 AM IST