Lupin’s alliance partner Caplin Steriles (Caplin) has received final approval from the United States Food and Drug Administration (USFDA) 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 around $36 million in the United States (IQVIA MAT for the 12-month period ending December 2022).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
