In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a EINECS 233-120-9 Drug Master File in Korea (EINECS 233-120-9 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of EINECS 233-120-9. The MFDS reviews the EINECS 233-120-9 KDMF as part of the drug registration process and uses the information provided in the EINECS 233-120-9 KDMF to evaluate the safety and efficacy of the drug.
After submitting a EINECS 233-120-9 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 EINECS 233-120-9 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of EINECS 233-120-9 suppliers with KDMF on PharmaCompass.