In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1,2-diaminocyclohexane platinum oxalate Drug Master File in Korea (1,2-diaminocyclohexane platinum oxalate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,2-diaminocyclohexane platinum oxalate. The MFDS reviews the 1,2-diaminocyclohexane platinum oxalate KDMF as part of the drug registration process and uses the information provided in the 1,2-diaminocyclohexane platinum oxalate KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1,2-diaminocyclohexane platinum oxalate 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 1,2-diaminocyclohexane platinum oxalate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1,2-diaminocyclohexane platinum oxalate suppliers with KDMF on PharmaCompass.