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