Lupin Launches Dapagliflozin Tablets in U.S. Market
Filing Summary
Lupin Limited has launched Dapagliflozin Tablets, 5 mg and 10 mg, in the United States. This follows the approval of its Abbreviated New Drug Application by the U.S. FDA. The tablets are bioequivalent to Farxiga®, a product of AstraZeneca AB, and are intended for the same indications as listed in the approved labeling. Lupin is a global pharmaceutical company with a strong presence in multiple therapy areas, including anti-diabetic medications, and operates in over 100 markets worldwide.
Lupin Limited has announced the launch of Dapagliflozin Tablets in the United States. The tablets are available in 5 mg and 10 mg dosages. This launch follows the approval of Lupin’s Abbreviated New Drug Application by the U.S. Food and Drug Administration (FDA). The tablets are bioequivalent to Farxiga®, a product of AstraZeneca AB, and are intended for the same indications as specified in the approved labeling.
The launch of Dapagliflozin Tablets marks an expansion of Lupin’s product offerings in the U.S. pharmaceutical market. The company specializes in both branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin’s product portfolio covers multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
Lupin operates 15 manufacturing sites and 7 research centers globally. The company employs over 24,000 professionals and distributes its products in more than 100 markets worldwide. Lupin’s subsidiaries include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions, which focus on improving patient health outcomes.
For further information, inquiries can be directed to Rajalakshmi Azariah, Vice President & Global Head of Corporate Communications at Lupin, or Elise Titan, Director of U.S. Communications at Lupin.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India. The company is committed to providing high-quality pharmaceutical products and improving patient health outcomes. Lupin maintains a strong position in the pharmaceutical industry, particularly in the U.S. and India, across various therapy areas.