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