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