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