SHILPA MEDICARE LTD. - 530549 - INTIMATION UNDER REGULATION 30 SEBI(LODR) 2015
This is to inform you that the Company has received U.S Food and Drug Administration 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 04 Oct 2019. Gemcitabine Injection, 200 mg/5.26 mL, 1 g/26.3 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. This is for your information and doing the needful.05-10-2019