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