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