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