Lupin Limited Receives U.S. FDA Approval for Dapagliflozin Tablets
Global pharmaceutical major Lupin Limited announced that it has secured approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin Tablets, available in 5 mg and 10 mg strengths.The U.S. FDA has approved Lupin's Dapagliflozin Tablets, 5 mg and 10 mg, noting that they are bioequivalent to Farxiga® for the indications specified in the approved labeling.
Lupin Limited, headquartered in Mumbai, India, operates as a global pharmaceutical leader with products distributed across over 100 markets. The company specializes in a diverse range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The company maintains a strong presence in India and the U.S., serving multiple therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin operates 15 state-of-the-art manufacturing sites and 7 research centers globally, supported by a workforce exceeding 24,000 professionals.
Lupin is further expanding its commitment to patient health outcomes through its subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
LUPIN Stock Price Movement
On Tuesday, Lupin Limited shares edged higher to close at ₹2298.3, marking a 0.66% gain for the stock. The equity settled amid solid trading volume, recording transactions across 546,081 shares.Source:
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