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