In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Luvatol MK 35 Drug Master File in Korea (Luvatol MK 35 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Luvatol MK 35. The MFDS reviews the Luvatol MK 35 KDMF as part of the drug registration process and uses the information provided in the Luvatol MK 35 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Luvatol MK 35 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 Luvatol MK 35 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Luvatol MK 35 suppliers with KDMF on PharmaCompass.