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