Prostor Pharma has obtained a license from the Ministry of Industry and Trade of the Russian Federation for the production of medicines for medical use and for conducting clinical trials at its own site in Yekaterinburg, the company’s press service reported to GxP News.
“The document confirms that the pharmaceutical production facility complies with licensing requirements, including conformity with Good Manufacturing Practice (GMP) rules,” the press service stated.
The site will produce the radiopharmaceutical drug “Radium chloride, 223Ra” for the treatment of patients with bone metastases in prostate cancer.
“By the end of this year, we also plan to start production of a drug based on lutetium (177Lu) oxodotreotide, which is used in the treatment of neuroendocrine tumors. Currently, the documentation for obtaining a registration certificate for this drug is under review by the Ministry of Health,” noted the company’s General Director, Alexander Zverev.
For the past year and a half, Prostor Pharma has been producing 223Ra under contract at the Ural Federal University. The company did not disclose the amount of investment in launching its own production facility.
As previously reported, the number of Russian medical centers using the radiopharmaceutical oncology drug based on radium chloride will increase from the current 40 to at least 50 in 2026.