Shilpa Medicare receives USFDA approval for Gemcitabine for Injection USP
Capital Market Shilpa Medicare has received U.S Food and Drug Administration approval for its ANDA, Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial. Gemcitabine for Injection USP is a generic equivalent of reference listed drug (RLD), GEMZAR used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer & pancreatic cancer as recommended in the label approved by FDA.
According to IQVIA MAT 12/2018, the US market for Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial is approximately US$ 11.7 million.
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