Alembic Pharma Gets Final USFDA Nod for Hypertension Drug

On November 11, 2024, Alembic Pharmaceuticals Ltd announced that it has received final approval from the US Food and Drug Administration for its Diltiazem Hydrochloride Extended-Release capsules, used for the treatment of hypertension.

What USFDA Approval Means for Alembic Pharmaceuticals?

This approval marks a significant milestone for the company, as Diltiazem Hydrochloride is commonly used to treat hypertension and angina. Alembic Pharmaceuticals intends to introduce the product in the U.S. market, enhancing its presence in the competitive cardiovascular market.

Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications. The approved strengths for the capsules include 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg.

The company has confirmed that the launch of the extended-release capsules will be in accordance with the established regulatory guidelines. This approval further strengthens Alembic’s product portfolio, which continues to expand globally in response to growing demand for affordable generics.

Market Potential for Diltiazem Hydrochloride

IQVIA estimates that the market for Diltiazem Hydrochloride Extended-Release Capsules will reach approximately US$105.3 million by June 2024. Furthermore, Alembic Pharmaceuticals has obtained a total of 218 ANDA approvals from the USFDA, including 191 final approvals and 27 tentative approvals.

Alembic Pharmaceuticals Share Price Performance

On November 11, 2024, Alembic Pharmaceuticals share price opened at ₹1,039 and was trading at ₹1,028.30 at 1:55 PM on the BSE.

About Alembic Pharmaceuticals

Alembic Pharmaceuticals Ltd is a global pharmaceutical company based in Vadodara, India, established in 1907. It is renowned for manufacturing and marketing a wide range of generic pharmaceuticals, active pharmaceutical ingredients (APIs), and over-the-counter (OTC) products. The company has a strong presence in both domestic and international markets, including the U.S., Europe, and other emerging markets.

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