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