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