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