In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a D-4-amino-3-isoxazolidinone Drug Master File in Korea (D-4-amino-3-isoxazolidinone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of D-4-amino-3-isoxazolidinone. The MFDS reviews the D-4-amino-3-isoxazolidinone KDMF as part of the drug registration process and uses the information provided in the D-4-amino-3-isoxazolidinone KDMF to evaluate the safety and efficacy of the drug.
After submitting a D-4-amino-3-isoxazolidinone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their D-4-amino-3-isoxazolidinone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of D-4-amino-3-isoxazolidinone suppliers with KDMF on PharmaCompass.