Shilpa Medicare receives USFDA approval for Gemcitabine for Injection USP

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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