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