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