In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CAS-94-36-0 Drug Master File in Korea (CAS-94-36-0 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CAS-94-36-0. The MFDS reviews the CAS-94-36-0 KDMF as part of the drug registration process and uses the information provided in the CAS-94-36-0 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CAS-94-36-0 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 CAS-94-36-0 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CAS-94-36-0 suppliers with KDMF on PharmaCompass.