Alembic Pharmaceuticals, one of India’s leading vertically integrated pharmaceutical companies, has announced a significant regulatory milestone with the final approval from the U.S. Food and Drug Administration (USFDA) for its generic Amlodipine and Atorvastatin tablets. This development further strengthens Alembic’s growing footprint in the U.S. generics market.

The approved product is a combination drug indicated for the management of high blood pressure (hypertension) and elevated cholesterol levels (hyperlipidemia). The tablets offer a therapeutic equivalent to Caduet, the branded reference listed drug developed by Pharmacia and Upjohn Co. LLC, across multiple dosage strengths.

Regulatory Approval Details

Alembic received the green light for the following dosage combinations:

• 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg
• 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg
• 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg

The approval was granted under the Abbreviated New Drug Application (ANDA) route, which facilitates the entry of cost-effective generic medicines into the U.S. healthcare system.

Strengthening U.S. Presence with Regulatory Approvals

With this latest approval, Alembic’s tally of USFDA-approved ANDAs has risen to 223, comprising 199 final approvals and 24 tentative approvals. This milestone underscores the company’s commitment to developing high-quality, affordable generic drugs for regulated markets.

Alembic’s manufacturing and R&D infrastructure—accredited by international regulatory bodies such as the USFDA, TGA, MHRA, and WHO-GMP—continues to play a pivotal role in expanding its global presence, especially in the U.S., which remains one of the most lucrative markets for Indian pharmaceutical exports.

Strategic Significance for Pharma Stakeholders

For stakeholders in India’s pharmaceutical ecosystem, Alembic’s success highlights several key trends:

• The growing demand for fixed-dose combination (FDC) therapies in chronic disease management.
• The role of Indian pharma companies in addressing U.S. drug affordability through generic alternatives.
• The competitive advantage of a strong regulatory track record in enhancing B2B licensing and supply partnerships.

As pricing pressures and regulatory scrutiny intensify in the global market, companies with robust development pipelines and compliance history, such as Alembic, are expected to become strategic allies for industry collaborators across formulations, contract manufacturing, and active pharmaceutical ingredient (API) supply chains.

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