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