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