Lupin in alliance with Natco Pharma has received final ANDA approval for Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base) from the United States Food and Drug Administration (USFDA) to market a generic version of Novartis Pharmaceuticals Corporation's (Novartis) Gleevec Tablets, 100mg and 400mg.
Lupin and Natco's Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base) is the generic version of Novartis' Gleevec Tablets, 100 mg and 400 mg. Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base) had annual sales of approximately $655 mn in the US (IQVIA MAT December 2018).
Lupin’s state-of-the-art Mihan facility at Nagpur commissioned recently has the production capabilities for injectables with vials, Iyophilised vials and Pre-filled Syringes (PFS). It received an EIR from USFDA in December 2018.
