Alembic Pharmaceuticals Limited has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets in strengths of 5 mg and 10 mg. The approved product is therapeutically equivalent to the reference listed drug, Farxiga (Dapagliflozin) Tablets, developed by AstraZeneca. Dapagliflozin belongs to the class of sodium-glucose cotransporter 2 (SGLT2) inhibitors and is prescribed for adults with type 2 diabetes mellitus. It is indicated to improve glycemic control alongside diet and exercise and to reduce the risk of hospitalization for heart failure in patients with cardiovascular risk factors.
Alembic was among the first applicants to submit a substantially complete ANDA for this product with a Paragraph IV certification. As a result, the company is eligible for 180 days of shared generic drug exclusivity in the United States market.
According to industry estimates, the market for Dapagliflozin tablets in these strengths was valued at approximately USD 10.5 billion for the twelve months ending December 2025, indicating a significant commercial opportunity.
With this latest approval, Alembic Pharmaceuticals continues to strengthen its presence in the global generics market. The company now holds a cumulative total of 235 ANDA approvals from the USFDA, including 217 final approvals and 18 tentative approvals.
Founded in 1907 and headquartered in India, Alembic Pharmaceuticals is a vertically integrated research and development-driven pharmaceutical company. It manufactures and markets a wide range of generic medicines across global markets, supported by state-of-the-art manufacturing and research facilities approved by leading regulatory authorities, including the USFDA.
The company is also a leader in branded generics within India, supported by a strong field force and a portfolio of widely recognized products. This latest approval further reinforces Alembic’s commitment to expanding access to affordable, high-quality medicines worldwide while strengthening its position in regulated international markets.
Alembic Pharmaceuticals is a vertically integrated research-driven pharmaceutical company with a legacy spanning more than a century. Headquartered in India, the company manufactures and markets a wide range of generic pharmaceutical products across global markets.
Its manufacturing and research facilities comply with stringent regulatory standards and are approved by leading global authorities, including the USFDA. Alembic has built a strong reputation in the branded generics segment in India, supported by a widespread field force of over 5,500 professionals.
The company continues to focus on expanding its product pipeline, strengthening its regulatory footprint, and enhancing its capabilities in complex generics and specialty segments. The latest approval reflects its ongoing commitment to delivering high-quality, affordable medicines to patients worldwide.
With a strong foundation in research, manufacturing excellence, and regulatory compliance, Alembic remains well-positioned to drive sustained growth in both domestic and international markets. Alembic Pharmaceuticals Limited is one of India’s oldest and most respected pharmaceutical companies, with a legacy that dates back to 1907. Headquartered in India, Alembic has built a strong global presence as a vertically integrated research-driven pharmaceutical company, focused on the development, manufacturing and marketing of high-quality generic medicines. The company operates across major therapeutic areas and supports healthcare systems worldwide through a wide portfolio of affordable formulations and active pharmaceutical ingredients.
A key strength of Alembic is its strong emphasis on research and development, backed by modern infrastructure and a consistent pipeline of new products for regulated and emerging markets. Its manufacturing facilities meet global standards and are approved by leading regulatory authorities, including the US Food & Drug Administration (USFDA). The company has secured a significant number of ANDA approvals in the United States, reflecting its capability in compliance-driven product development and execution.
