This chemotherapy drug, called INFUGEM 10 mg/mL, is a combination of gemcitabine in 0.9% sodium chloride injection used in treatment of cancer
Sun Pharma, India’s largest drug maker, on Wednesday said it got its first-ever USFDA approval for a product filed from the Halol facility in Gujarat after receipt of Establishment Inspection Report (EIR) last month.
EIR indicates closure of US FDA inspection.
This chemotherapy drug, called INFUGEM 10 mg/mL, is a combination of gemcitabine in 0.9% sodium chloride injection used in treatment of cancer.
The addressable market size is approximately $35 million for the 12 months ending March 2018, as per IQVIA.
related news
US FDA in June concluded that the agency’s inspection of Halol site is closed and the issues contained in the Warning Letter issued in December 2015 have been addressed, paving the way for fresh approvals.
US FDA blocked approvals of Sun Pharma's largest manufacturing site Halol due to deviations of current good manufacturing practices.
Read here, on how Sun Pharma managed to get its Halol facility off the USFDA hook.
“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,” Gandhi added.
Shares of Sun Pharma rose 0.43 percent and were trading at Rs 551.15 on BSE at 12.15 pm, the benchmark Sensex gained 0.07 percent to 36,544.80 points.