Sun Pharmaceutical Industries including its subsidiaries and/or associate companies has received approval from the US Food and Drug Administration (USFDA) 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 USFDA 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.
The addressable market size is approximately $35 million for the 12 months ending March 2018, as per IQVIA.
Sun Pharmaceutical Industries is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.
