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