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