Alembic Pharmaceuticals Receives US FDA Nod For Diltiazem Hydrochloride Capsules To Treat Hypertension

Alembic Pharmaceuticals Ltd. announced on Monday that it has received final approval from the US Food & Drug Administration for capsules to treat hypertension.

The company has received the abbreviated new drug application, or ANDA, approval for Diltiazem Hydrochloride extended-release capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, as per an exchange filing.

Diltiazem hydrochloride extended-release capsules USPs are indicated for the treatment of hypertension. The capsules may be used alone or in combination with other antihypertensive medications. It is also indicated for the management of chronic stable angina and angina due to coronary artery spasm. Refer to the label for a detailed indication.

The approved ANDA is therapeutically equivalent to the reference listed drug product, Cardizem CD extended-release capsules, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, of Bausch Health US, LLC.

Diltiazem hydrochloride extended-release capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of $105.3 million for twelve months ending June 2024, according to IQVIA.

Alembic has a cumulative total of 218 ANDA approvals (191 final approvals and 27 tentative approvals) from the US FDA.

Shares of Alembic Pharmaceuticals closed 0.59% lower to Rs 1,032.05 apiece, compared to a 0.03% decline at the benchmark NSE Nifty 50.

It has risen 42.04% in the last 12 months and 35.90% on a year-to-date basis. The total traded volume in the day stood at 0.12 times its 30-day average. The relative strength index was at 33.17.

Seven out of the 16 analysts tracking the company have a 'buy' rating on the stock, six recommend a 'hold' and three suggest a 'sell,' according to Bloomberg data. The average of 12-month analyst price targets implies a potential upside of 10.4%.