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