Shilpa Medicare receives USFDA approval for Gemcitabine Injection

Shilpa Medicare has received US Food and Drug Administration final approval for its ANDA, Gemcitabine Injection, 200 mg/5.26 mL, 1 9/263 mL, and 2 g/52.6 mL (38 mg/mL) Single-dose vials on 04 October 2019.

Gemcitabine Injection, 200 mg/5.26 mL, 1 9/263 mL, and 2 g/52.6 mL (38 mg/mL) is used in the treatment of Ovarian Cancer, Breast Cancer, Non-Small Cell Lung Cancer and Pancreatic Cancer as recommended in the label approved by FDA.

According to IQVIA MAT Q2 2019 data, the US market for Gemcitabine Injection, 38 mg/mL is approximately US$ 14.9 Million.

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