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