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