Alembic secures USFDA nod for generic Diltiazem

INDIA—Alembic Pharmaceuticals Ltd, a prominent Indian pharmaceutical company, has gained final approval from the U.S. Food and Drug Administration (USFDA) for its generic Diltiazem Hydrochloride extended-release capsules.

These capsules, available in strengths of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, are designed to treat hypertension and may be used alone or in combination with other antihypertensive medications.

 Additionally, the capsules are indicated for the management of chronic stable angina and angina caused by coronary artery spasms.

According to Alembic, approving its generic version of Diltiazem Hydrochloride Extended-Release Capsules brings a more affordable alternative to the brand-name Cardizem CD, which Bausch Health currently markets in the U.S.

IQVIA data reported that the market for this treatment was valued at approximately $105.3 million over the twelve months ending June 2024.

This approval will strengthen Alembic’s position in the competitive U.S. generics market.

The company now has a total of 218 ANDA (Abbreviated New Drug Application) approvals from the USFDA, including 191 final approvals and 27 tentative ones.

Alembic’s achievement in securing this approval highlights its ongoing commitment to expanding its portfolio of generics in the U.S., a key market for the company.

Last month, the USFDA completed an inspection of Alembic’s oncology formulation facility in Panelav, Gujarat, with no observations or objections, reflecting the high standards of its manufacturing processes.

This facility inspection, conducted on October 7 and 8, adds to Alembic’s reputation for meeting rigorous regulatory standards.

Founded in 1907, Alembic Pharmaceuticals has a well-established legacy in research and development, which is supported by its advanced manufacturing capabilities.

The company’s state-of-the-art facilities meet regulatory requirements in multiple countries, including those set by the US FDA.

 In addition to its U.S. operations, Alembic maintains a strong presence in the Indian market, where it leads in branded generics, supported by a dedicated workforce of over 5,200 professionals.

Alembic’s latest approval not only expands its U.S. product offerings but also emphasizes the company’s growth and influence in the global pharmaceutical industry, both in generics and branded medications.

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