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