Lupin Limited today announced that its alliance partner Caplin Steriles Limited (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, via an exchange filing.
The approved dosages are 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 U.S. (IQVIA MAT for the 12-month period ending December 2022).
