Lupin Secures US FDA Approval for Fluconazole Tablets, USP

India Pharma Outlook Team | Monday, 23 October 2023

 India Pharma Outlook Team

Lupin Limited (Lupin) announced that the United States Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application for fluconazole tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg, to market a generic equivalent of Pfizer, Inc.'s Diflucan tablets, 50 mg, 100 mg, 150 mg, and 200 mg. Lupin's Pithampur factory in India will manufacture this product. Fluconazole pills In the United States, USP (RLD Diflucan) has a projected annual sales of USD 43 million (IQVIA MAT July 2023).

Lupin is a worldwide pharmaceutical firm based in Mumbai, India that focuses on innovation. The firm develops and commercializes adiverse variety of branded and generic formulations, biotechnology products , and APIs in over 100 markets worldwide, including the United States, India, South Africa, and Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East, as per pharmabiz. Lupin began as a vitamin company, but quickly expanded into the production of tuberculosis (TB) medications. Despite the government's pricing limitations on anti-TB drugs, the decision was based on DBG's aim to decrease the burden of one of India's most prevalent and debilitating diseases.

Lupin has grown and extended into new areas and locations over the years, producing pharmaceuticals that provide the promise of excellent health to populations all around the world. Lupin's current global footprint encompasses 11 nations and six continents, having begun with two people — a peon-cum-packer and a part-time typewriter. This trip has been made possible by Mr. Desh Bandhu Gupta's vision and conviction.

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