Shilpa Medicare has received US Food and Drug Administration (USFDA) final approval for its ANDA, Gemcitabine Injection, 200 mg/5.26 mL, 1 g/26.3 mL, and 2 g/52.6 mL (38 mg/mL) Single-dose vials on October 04, 2019.
Gemcitabine Injection 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 $14.9 million.
Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.
