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