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New Delhi: The country's largest drug manufacturer, Sun Pharmaceutical Industries Ltd, has received its first approval in five years for a product manufactured at its Halol, Gujarat plant, by the US Food and Drug Administration (USFDA)
Infugem, The Halol Generating Station was under USFDA control since September 2014 and the quality cloud on it was lifted only last. Settlement of the case allowed Sun Pharma to resume sales in the US market from this facility, which accounts for 35 to 40% of the company's revenue.
"This is the USFDA's first product approval of Hal Pharma after receiving the report of inspectio n of the establishment (EIR) in June 2018, "said Sun Pharma.
USFDA approval is for the injection of Infugem (gemcitabine in 0.9% sodium chloride injection) 10 mg / mL, for l & # 39; Intravenous use in a bag ready to administer. The product will be added to the oncology product portfolio of the pharmaceutical company. The technology used to formulate Infugem eliminates the risks badociated with the compounding, an additional step in the administration of cytotoxic infusion products, the company said.
"said Abhay Gandhi, chief executive officer of Sun Pharma in North America.
Infugem uses patented technology to pre-mix cytotoxic products in oncology in a sterile environment and provide them to prescribers in real time. – administer infusion bags.
According to the pharmaceutical company, the product offers greater safety by preventing problems of "over or under dosing". It also warns of "the risk of contamination that can lead to infections," said Sun Pharma.
In December 2015, Halol's factory of the company received a warning letter, following an inspection that revealed quality problems. Since then, no new product manufactured in the factory has been approved.
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