Xbrane Biopharma recently announced that its subsidiary, Primm Pharma, has submitted an application for the GMP (good manufacturing practice) approval of its Spherotide production facility, located just outside of Naples, Italy, to the Italian Medicines Agency, AIFA.
The AIFA evaluation process will take six months to complete and will include a visit to the facility. If the process goes well, an approval will be granted early next year.
"We are very happy to submit the application for GMP approval to AIFA in line with our time plan,” Xbrane Biopharma CEO Martin Amark said. “The GMP approval is a critical step for us in the development process towards market approval and initiated sales of Spherotide in Iran and other markets."
Spherotide consists of a combined formula that includes GnRH analogue triptorelin, which is used to treat prostate cancer, endometriosis and uterine fibroids. If Spherotide is approved by AIFA, it will be available to use on humans, which is a crucial step in its development.
Xbrane acquired Primm Pharma with a convertible note, which can be converted into Xbrane shares if six milestones involving Spherotide are reached. The GMP application submission is the first milestone.
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