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