New Delhi: The country’s largest drug maker, Sun Pharmaceutical Industries Ltd, has received its first approval in five years for a product manufactured at its Halol, Gujarat, plant from the US Food and Drug Administration (USFDA).
Infugem, which is used for the treatment of cancer and is manufactured at its Halol facility, received the USFDA approval on Wednesday, the company said.
The Halol plant had been under USFDA scanner since September 2014 and the quality cloud over it was lifted only last month. The resolution of the issue paved the way for Sun Pharma to resume selling to the US market from this facility, which accounts for 35-40% of the revenue for the company.
“This is the first USFDA approval for the product from Sun Pharma’s Halol facility post receipt of the Establishment Inspection Report (EIR) in June 2018,” Sun Pharma said.
The USFDA approval is for Infugem injection (gemcitabine in 0.9% sodium chloride injection) 10 mg/mL, for intravenous use in a ready-to-administer bag. The product will add to the drug firm’s expanding oncology portfolio of novel products. It had an addressable market size of about $35 million for the 12 months ended March 2018, the company said.
“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, Sun Pharma’s North America chief executive officer.
Infugem uses a proprietary technology that allows cytotoxic oncology products to be premixed in a sterile environment and supplied to the prescribers in ready-to-administer infusion bags.
According to the pharma firm, the product provides greater safety by preventing problems of “over or under dosing”. It also prevents “the risk of contamination that can lead to infections”, Sun Pharma said.
In December 2015, the company’s Halol plant was served a warning letter, following an inspection that revealed quality issues. Since then, no new products manufactured at the facility have been approved.