Alembic Pharma bags USFDA nod for hypertension drug Diltiazem Hydrochloride ER

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-11-11 06:35 GMT | Update On 2024-11-11 06:35 GMT

Vadodara: Alembic Pharmaceuticals Limited has announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), 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 are indicated for the treatment of hypertension. Diltiazem hydrochloride 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.

Hypertension, also known as high blood pressure, is a medical condition where the force of the blood against the walls of the arteries is consistently too high. It is a common condition that can lead to serious health problems, such as heart disease, stroke, kidney damage, and more, if left untreated.

Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of US$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 USFDA.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Alembic Pharma bags USFDA nod for hypertension drug Diltiazem Hydrochloride ER

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