Global pharma major Lupin Limited (Lupin) announced that its alliance partner Caplin Steriles Limited (Caplin) has received final approval from the United States Food and Drug Administration (FDA) for its Abbreviated new Drug Application (ANDA) thiamine hydrochloride injection USP, 200 mg/2 mL (100 mg/mL) multiple-dose vials, to market 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 USP had an annual sale of approximately USD 36 million in the US (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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
