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