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