In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CRL 40982 Drug Master File in Korea (CRL 40982 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CRL 40982. The MFDS reviews the CRL 40982 KDMF as part of the drug registration process and uses the information provided in the CRL 40982 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CRL 40982 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 CRL 40982 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CRL 40982 suppliers with KDMF on PharmaCompass.