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