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