Mumbai, India & Princeton, NJ, April 8, 2019 — – Sun Pharmaceutical Industries Ltd. (Reuters:
SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its
subsidiaries and/or associate companies) today announced that INFUGEM™ (gemcitabine in sodium
chloride injection), for intravenous use, is now commercially available in the U.S. INFUGEM, the first
chemotherapy product that comes in a premixed, ready-to-infuse formulation, was approved by the
U.S. Food and Drug Administration (FDA) in July 2018 in combination with other drugs for the
treatment of breast, ovarian, non-small cell lung cancers, and as a single agent for the treatment of
pancreatic cancer.
INFUGEM is an alcohol-free, clear, colorless, sterile solution of 10mg/mL gemcitabine in 0.9% sodium
chloride that is supplied to pharmacists in ready-to-infuse bags as a Spike & Go™ package. It involves
dose banding practice, whereby standardized doses of intravenous cytotoxic drugs are used for
ranges (or “bands”) of doses calculated for individual patients. INFUGEM is the only available
gemcitabine formulation that does not require reconstitution and syringe withdrawal prior to
intravenous administration. Eliminating these steps reduces complexity and minimizes the inherent
risks of hazardous drug exposure, contamination, and medication errors.
“INFUGEM is an example of our focus at Sun Pharma, which is to improve provider and patient
experiences by using high-tech delivery systems and/or novel formulations for gold-standard
medicines,” said Abhay Gandhi, CEO-North America, Sun Pharma. “With an increasing number of
organizations strongly recommending the use of premixed parenteral products due to concerns
related to manual compounding, and with the broad use of gemcitabine to treat various cancers, the
timing couldn’t be better to launch INFUGEM in the U.S.”

INFUGEM is the first product using Sun’s proprietary technology which allows cytotoxic oncology
products to be premixed in a sterile environment and supplied to the prescribers in ready-to-infuse
final dosage bags. The product is stable at room temperature storage conditions for two years, even
without the use of alcohol and other preservatives in the bag. By contrast, other gemcitabine
products require reconstitution and/or dilution for patient use, and remain stable at room
temperature for only 24 hours.
“The availability of gemcitabine in ready-to-infuse bags is a welcome development, simplifying the
complex delivery of this vital chemotherapy medication,” commented Jeff Lombardo PharmD, BCOP,
Research Assistant Professor, Center of Integrated Global Biomedical Sciences, University at Buffalo.
For more information about INFUGEM, please visit

Media Contact :
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