Granules India gets USFDA nod for generic Prazosin Hydrochloride capsules

The US Food & Drug Administration (USFDA) granted approval to the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI) — a wholly owned foreign subsidiary of the company — for Prazosin Hydrochloride capsules, of strengths 1mg, 2mg and 5mg, Granules India Limited said in a statement.

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Pharmaceuticals firm Granules India Ltd on Tuesday said it has received approval from the US health regulator for its generic Prazosin Hydrochloride capsules used for the treatment of high blood pressure.

The US Food & Drug Administration (USFDA) granted approval to the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI) — a wholly owned foreign subsidiary of the company — for Prazosin Hydrochloride capsules, of strengths 1mg, 2mg and 5mg, Granules India Limited said in a statement.

These capsules are bioequivalent to the reference listed drug product, Mini plus capsules 1mg, 2mg and 5mg of Pfizer Inc, it said, adding the product would be available for the US market shortly.

Commenting on the approval, GPI Executive Director Priyanka Chigurupati said, “We are pleased to receive the approval of the product and will surely be a valuable addition to our growing product portfolio in the US market.”

Citing IQVIA/IMS Health data, the company said the current annual US market for Prazosin Hydrochloride 1mg, 2mg, 5mg strengths is approximately USD 54 million.

With the latest approval, Granules now has a total of 46 abbreviated new drug application (ANDA) approvals from USFDA (44 final approvals and two tentative approvals).