Shilpa Medicare gets USFDA approval for Gemcitabine Injection

07 Oct 2019 Evaluate

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.

Shilpa Medicare Share Price

331.70 -3.15 (-0.94%)
10-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1786.25
Dr. Reddys Lab 1251.10
Cipla 1489.15
Zydus Lifesciences 923.70
Lupin 2055.05
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