DuchemBio Registers Key Raw Material for Parkinson's Disease PET Diagnostic Agent with U.S. FDA

[Financial News] DuchemBio, a company specializing in radiopharmaceuticals, has completed the U.S. Food and Drug Administration (FDA) Drug Master File (DMF) registration for the key raw material used in its Parkinson's disease (PD) diagnostic PET (positron emission tomography) radiopharmaceutical, 18F-FP-CIT, laying the foundation for entry into the North American market.
DuchemBio said on the 24th that the key raw material for 18F-FP-CIT has completed FDA DMF registration. After completing the registration process, the FDA assigned the material the unique number "MF044308."
DMF registration is one of the procedures required to manufacture and sell pharmaceuticals in the United States. It is a system in which manufacturers submit information on the production process and quality control of raw materials to the FDA for review and approval. Because the registered DMF can be used in the approval process for finished drugs, it is considered an essential requirement for entering the U.S. market.
With this registration, DuchemBio has secured the supply requirements for North America, the world's largest radiopharmaceutical market, and expects to accelerate negotiations on technology exports. The company currently holds global rights to 18F-FP-CIT and has signed technology transfer agreements with 12 Asia-Pacific countries.
18F-FP-CIT is a PET diagnostic agent that uses the radioactive isotope fluorine-18 to image dopamine transporters in the brain, and it is used for the early diagnosis of degenerative brain diseases such as PD. DuchemBio explained that it applies a high-performance liquid chromatography (HPLC) process to production of the key raw material, precisely removing impurities and managing manufacturing records to ensure consistent quality.
DuchemBio had previously secured a U.S. patent for an AI-based technology that generates early diagnostic images linked to 18F-FP-CIT. Using only the initial images taken after injection, the technology has AI predict and generate high-resolution images from the point at which drug distribution is complete. This shortens test times and allows more examinations to be performed in the same period.
Kim Sang-woo, CEO of DuchemBio, said, "In addition to securing a U.S. patent, this DMF registration has given us the supply foundation needed to enter the North American market." He added, "We will complete the ongoing software approval process and expand the technological competitiveness we have secured in PD diagnostics into the AD diagnostic field as well."
[email protected] Jung Sang-hee Reporter