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Shilpa Medicare gets USFDA’s approval for Bortezomib for Injection

09 Apr 2019 Evaluate

Shilpa Medicare has received the US Food and Drug Administration’s (USFDA) tentative approval for its ANDA, Bortezomib for Injection, 3.5mg/vial. Bortezomib for Injection, 3.5mg/vial is a generic equivalent of reference listed drug (RLD), VELCADE used in the treatment of patients with multiple myeloma and Mantle Cell Lymphoma as recommended in the label approved by USFDA.

According to IQVIA MAT Q4 2018 data, the US market for Bortezomib for Injection 3.5 mg/vial is approximately $609 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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