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