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