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Shilpa Medicare receives USFDA’s final approval for Docetaxel Injection

17 May 2019 Evaluate

Shilpa Medicare has received US Food and Drug Administration’s (USFDA) final approval for its ANDA, Docetaxel Injection USP, 20 mg/mL, 80 mg/4 mL (20 mg/mL), and 160 mg/8 mL (20 mg/mL).

Docetaxel Injection USP, 20 mg/mL, 80 mg/4 mL and 160 mg/8 mL is a generic equivalent of reference listed drug (RLD) Taxotere used in the treatment of Breast Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Gastric Adenocarcinoma, Head and Neck Cancer as recommended in the label approved by USFDA.

According to IQVIA MAT Q1 2019 data, the US market for Docetaxel Injection USP is approximately $32.13 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. 1853.50
Dr. Reddys Labs. 1202.80
Cipla 1397.20
Lupin 2090.00
Zydus Lifesciences 1202.00
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