Lupin Gets USFDA Nod For Generic Cancer Treatment Drug

Mumbai: Global pharma major Lupin Limited (Lupin) in partnership with Pharmascience Inc. today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, to market a generic equivalent of Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company.

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).

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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 U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 8.7% of its revenue in research and development in FY22.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.

Pharmascience Inc. is one of the largest pharmaceutical manufacturers in Canada specialized in complex generics Pharmascience delivers high-quality medicines globally in over 50 countries worldwide.

Pharmascience's products are developed with the highest international regulatory standards in addition to industry best practices and are distributed as FDA certified generic products in the United States. Pharmascience's global presence and agile business development model provide healthcare communities around the world with the high-quality Canadian medicines to respond to patients' quality of life needs.

Pharmascience's R&D team has the extensive expertise necessary for the development of complex injectable and solid oral generic drugs. Pharmascience has invested over $750M in research and development and ranks amongst the top generic manufacturers in Canada, offering over 300 product families, 1,400 stock keeping unit (SKUs) in more than 20 dosage forms delivering over 2.5 billion units in finished dosage forms.

Also Read:Lupin to acquire diabetes brands Ondero, Ondero-Met from Boehringer Ingelheim for Rs 207 crore