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