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