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