Shilpa Medicare gets final USFDA approval for Gemcitabine Injection

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 the USFDA.

New Delhi: Drug firm Shilpa Medicare recently said it has received final approval from the US health regulator 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.

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 the USFDA.

"The Company 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 Oct 2019," Shilpa Medicare said in a filing.

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

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989.

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