Lupin alliance partner Caplin Steriles bags USFDA okay for Thiamine Hydrochloride Injection
Mumbai: Pharma major Lupin Limited today announced that its alliance partner Caplin Steriles Limited has received final approval from the United States Food and Drug Administration (U.S.FDA) for its Abbreviated new Drug Application (ANDA) Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials.
The product is a therapeutically equivalent to the reference listed drug (RLD), Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100mg/mL), of Fresenius Kabi USA LLC.
Thiamine Hydrochloride injection is used to treat thiamine deficiency or beriberi whether of the wet (major symptoms related to the cardiovascular system) or dry (major symptoms related to the nervous system) variety.
Thiamine Hydrochloride Injection USP had an annual sale of approximately USD 36 million in the U.S. (IQVIA MAT for the 12-month period ending December 2022)
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 specializes 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.
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