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