Alembic Pharma Gets USFDA Nod for Diabetes Drug in US

Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its dapagliflozin tablets in 5 mg and 10 mg strengths. This approval marks another important step in the company’s effort to grow its presence in the US generics market.

The approval was granted under the Abbreviated New Drug Application (ANDA) pathway, confirming that Alembic’s version is equivalent to the branded drug Farxiga, originally developed by AstraZeneca. Dapagliflozin is part of a class of medicines known as SGLT2 inhibitors, which are commonly used to manage type 2 diabetes.

The drug helps control blood sugar levels in adults with type 2 diabetes and is also prescribed to reduce the risk of hospitalization due to heart failure treatment in patients with existing cardiovascular conditions or risk factors. With lifestyle-related diseases on the rise globally, demand for such treatments has been steadily increasing.

Alembic was among the early applicants to file a complete ANDA with a Paragraph IV certification for this drug. As a result, the company is eligible for 180 days generic exclusivity in the US market. This gives it a valuable opportunity to enter the market early and compete effectively.

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According to market data, dapagliflozin recorded sales of around $10.48 billion in the United States for the 12 months ending December 2025. This highlights the strong US pharmaceutical market potential of the product and makes it a key addition to Alembic’s portfolio.

With this approval, Alembic’s total USFDA approvals have reached 235, including 217 final approvals and 18 tentative ones. This reflects the company’s consistent focus on research, development, and regulatory compliance in the generic drug industry.

Overall, this move strengthens Alembic’s position in high-demand therapeutic areas like diabetes and heart care. It also supports the company’s broader goal of providing affordable medicines globally while expanding its footprint in the cardiovascular and diabetes segment.