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