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Shilpa Medicare receives USFDA’s approval for Busulfan Injection

Mumbai : Shilpa Medicare has received US Food and Drug Administration’s (USFDA) approval for its ANDA, Busulfan Injection, 60 mg/10 ml. Busulfan Injection, 60 mg/10 ml is a generic equivalent of reference listed drug (RLD), Busulfex Injection, 60 mg/10 ml, used in the treatment of patients with chronic myelogenous leukemia as recommended in the label approved by USFDA.

According to IQVIA MAT Q4 2018 data, the US market for Busulfan Injection, 60 mg/10 ml is approximately $32.8 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.

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