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