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