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