Comments
Sun Pharmaceutical Industries has received approval from the US health regulator for its INFUGEM injection used for the treatment of cancer.
This is the first US Food and Drug Administration (USFDA) approval for a product from the company’s Halol facility after the receipt of Establishment Inspection Report (EIR) in June 2018, Sun Pharma said in a statement today.
The USFDA approval 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.
Sun Pharma’s 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.”
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, he added.
As per IQVIA, “The addressable market size is approximately $35 million for the 12 months ending March 2018”, Sun Pharma said.
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.
Sun Pharma shares were trading down by 0.26 per cent at Rs 547.35 on the BSE.
Comments
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.