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