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March 2019

Premixed Oncology Injection

Sun Pharmaceutical Industries Ltd

Sun Pharma has received approval from the US Food and Drug Administration for INFUGEM (gemcitabine in 0.9% sodium chloride injection) 10 mg/mL, for intravenous use in a ready-to-administer (RTA) bag. INFUGEM uses a proprietary technology that allows cytotoxic oncology products to be premixed in a sterile environment and supplied in RTA infusion bags. It involves a dose banding practice, whereby standardized doses of intravenous cytotoxic drugs are used for ranges (or bands) of doses calculated for individual patients. The RTA bags are designed to improve safety by reducing the risk of over- or under-dosing, and reducing the risk of contamination that can lead to infection.

Sun Pharmaceutical Industries, Ltd

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