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