It is the first US FDA approval for a product from the Halol facility post receipt of EIR
Sun Pharmaceutical has announced that it has received approval from the US Food and Drug Administration (US FDA) for INFUGEM (gemcitabine in 0.9% sodium chloride injection) 10 mg/ml, for intravenous use in a ready-to-administer (RTA) bag. This is the first US FDA approval for a product from Sun Pharma’s Halol facility post receipt of Establishment Inspection Report (EIR) in June 2018.
INFUGEM uses a proprietary technology which allows cytotoxic oncology products to be premixed in a sterile environment and supplied to the prescribers in RTA infusion bags. It involves dose banding practice, whereby standardised doses of intravenous cytotoxic drugs are used for ranges (or bands) of doses calculated for individual patients. The RTA bags will provide greater safety by preventing problems of over or under-dosing, preventing the risk of contamination that can lead to infections, and by taking care of problems associated with, and precautions to be taken while, handling cytotoxic drugs by healthcare providers.
“The technology used to formulate INFUGEM eliminates the risks associated with compounding, an extra step in the administration of cytotoxic infusion products, providing improved safety for healthcare professionals and cancer patients,” said Abhay Gandhi, CEO – North America, Sun Pharma. “We’re pleased to add this novel product to our expanding oncology portfolio, as gemcitabine is one of the most commonly used cytotoxics in oncology practices.”