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