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