Alembic Pharma Gets USFDA Approval for Hypertension Drug Diltiazem ER

Alembic Pharmaceuticals Limited informed the stock exchanges that the company has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP in 120 mg, 180 mg, and 240 mg dosages. 

The company added that this ANDA is therapeutically equivalent to the reference listed drug, Dilacor XR Extended-Release Capsules, produced by Allergan Sales LLC. 

Diltiazem Hydrochloride Extended-Release Capsules are indicated for the treatment of hypertension and can be used as a standalone treatment or in combination with other antihypertensive drugs, such as diuretics. Additionally, Diltiazem is prescribed for managing chronic stable angina. For detailed indications, patients and healthcare providers are advised to refer to the product label.

According to IQVIA data, the market size for Diltiazem Hydrochloride Extended-Release Capsules USP, in the 120 mg, 180 mg, and 240 mg strengths, was approximately US$ 28.2 million for the 12 months ending in June 2024.

This approval further strengthens Alembic’s portfolio in the US market. The company now has a cumulative total of 217 ANDA approvals from the USFDA, which includes 190 final approvals and 27 tentative approvals. This milestone demonstrates Alembic’s consistent focus on expanding its presence in the global pharmaceutical market.

Earlier this month, in October, the company announced that it had completed the United States Food and Drug Administration inspection for its Oncology (Injectable and Oral Solid) Formulation Facility (F-2) located at Panelav. The inspection was successfully completed without any Form 483 observation. The inspection was conducted from October 7, 2024, to October 8, 2024. 

On October 21, 2024, Alembic Pharmaceuticals share price opened at ₹1,170.25, touching the day’s high at ₹1,188.00, as of 9:58 AM on the NSE.

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