Lupin Launches Anti-Diabetic Tablets In The US Market Following USFDA Approval

Lupin has launched Dapagliflozin Tablets in the United States in 5 mg and 10 mg strengths after receiving USFDA approval for its abbreviated new drug application. The product is bioequivalent to Farxiga and will be used for approved indications in the US market. This launch strengthens Lupin’s presence in the anti-diabetic segment and expands its portfolio in one of its key global markets.

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Tresha Dias Updated: Saturday, April 11, 2026, 09:50 AM IST
Lupin has launched Dapagliflozin Tablets in the United States in 5 mg and 10 mg strengths after receiving USFDA approval for its abbreviated new drug application.  |

Lupin has launched Dapagliflozin Tablets in the United States in 5 mg and 10 mg strengths after receiving USFDA approval for its abbreviated new drug application. |

Mumbai/Naples: Lupin is expanding its US portfolio with a fresh product launch, targeting a key therapy segment in the pharmaceutical market.

Launches Diabetes Drug

Lupin Limited announced the launch of Dapagliflozin Tablets in the United States in strengths of 5 mg and 10 mg. The launch follows approval of its abbreviated new drug application by the US Food and Drug Administration, enabling the company to market the product in one of its largest global markets.

Gains Regulatory Approval

The approval confirms that Lupin’s product is bioequivalent to Farxiga, allowing it to be prescribed for the same approved indications. This regulatory clearance is a key step for generic pharmaceutical companies, ensuring that the product meets required standards of quality, safety, and efficacy. The development allows Lupin to compete directly in the established anti-diabetic treatment space.

Expands US Portfolio

The launch adds to Lupin’s growing portfolio in the United States, a market where it already maintains a strong presence across multiple therapy areas. The company’s focus on complex generics and specialty products continues to drive its expansion strategy. By introducing Dapagliflozin Tablets, Lupin strengthens its offerings in the cardiovascular and anti-diabetic segments, which remain critical growth areas.

Supports Global Strategy

Lupin operates across more than 100 markets and has built a diversified portfolio spanning branded and generic formulations, biotechnology products, and active pharmaceutical ingredients. With 15 manufacturing sites and 7 research centers globally, the company continues to invest in product development and innovation. This latest launch reflects its ongoing efforts to enhance patient access to affordable medicines while expanding its global footprint.

The launch of Dapagliflozin Tablets marks another step in Lupin’s strategy to strengthen its presence in regulated markets, reinforcing its position in the global pharmaceutical industry.

Disclaimer: This article is based solely on the contents of the company’s press release dated April 10, 2026, and does not include information from external sources or independent verification.

Published on: Saturday, April 11, 2026, 09:50 AM IST

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