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