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Shilpa Medicare gets USFDA’s approval for Gemcitabine for Injection

25 Feb 2019 Evaluate

Shilpa Medicare has received US Food and Drug Administration’s (USFDA) approval for its ANDA, Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial. Gemcitabine for Injection USP is a generic equivalent of reference listed drug (RLD), GEMZAR used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer & pancreatic cancer as recommended in the label approved by USFDA.

According to IQVIA MAT 12/2018, the US market for Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial is approximately $11.7 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.

Peers
Company Name CMP
Sun Pharma. Inds. 1760.00
Dr. Reddys Labs. 1231.85
Cipla 1325.00
Lupin 1955.80
Zydus Lifesciences 1124.30
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