Drug major Sun Pharmaceutical Industries today said it has received approval from the US health regulator for its INFUGEM injection used for treatment of cancer.
This is the first US Food and Drug Administration (USFDA) approval for a product from the company's Halol facility after receipt of Establishment Inspection Report (EIR) in June 2018, Sun Pharma said in a statement.
The approval from the USFDA is for INFUGEM injection (gemcitabine in 0.9 per cent sodium chloride injection) 10 mg/mL, for intravenous use in a ready-to-administer bag, it added.
Sun Pharma, North America CEO, Abhay Gandhi said, "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."
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