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