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