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