Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for dapagliflozin tablets, 5 mg, and 10 mg to market a generic equivalent of Farxiga tablets, 5 mg, and 10 mg of AstraZeneca AB. This product will be manufactured at Lupin’s Pithampur facility in India.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
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