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