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