Global pharma major Lupin Limited (Lupin) today announced the launch of Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials, after Lupin’s alliance partner Caplin Steriles Limited (Caplin) received an approval for its ANDA from the United States Food and Drug Administration (U.S. FDA).
Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials is 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 estimated annual sales of USD 35 million in the U.S.
Lupin received USFDA approval for Obeticholic Acid Tablets
Lupin last month received USFDA approval for its Abbreviated New Drug Application for Obeticholic Acid Tablets, 5 mg and 10 mg, a generic equivalent of Ocaliva Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc.
Lupin shares
The shares of Lupin on Monday at 10:48 am IST were at Rs 829.85, down by 0.072 per cent.