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