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