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Shilpa Medicare gets final USFDA approval for Gemcitabine Injection

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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.

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“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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Also Read: Shilpa Medicare gets USFDA nod for Irinotecan injection to treat cancer

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.

Also Read: Shilpa Medicare gets USFDA nod for Gemcitabine to treat types of cancer


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