In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a NK 1611 Drug Master File in Korea (NK 1611 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NK 1611. The MFDS reviews the NK 1611 KDMF as part of the drug registration process and uses the information provided in the NK 1611 KDMF to evaluate the safety and efficacy of the drug.
After submitting a NK 1611 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 NK 1611 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of NK 1611 suppliers with KDMF on PharmaCompass.