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