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