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