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