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