In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CS-2362 Drug Master File in Korea (CS-2362 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CS-2362. The MFDS reviews the CS-2362 KDMF as part of the drug registration process and uses the information provided in the CS-2362 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CS-2362 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 CS-2362 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CS-2362 suppliers with KDMF on PharmaCompass.