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