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