In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Durcal 2NH Drug Master File in Korea (Durcal 2NH KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Durcal 2NH. The MFDS reviews the Durcal 2NH KDMF as part of the drug registration process and uses the information provided in the Durcal 2NH KDMF to evaluate the safety and efficacy of the drug.
After submitting a Durcal 2NH 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 Durcal 2NH API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Durcal 2NH suppliers with KDMF on PharmaCompass.