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