In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a (R,S)-4-Amino-5-hexenoic acid Drug Master File in Korea ((R,S)-4-Amino-5-hexenoic acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (R,S)-4-Amino-5-hexenoic acid. The MFDS reviews the (R,S)-4-Amino-5-hexenoic acid KDMF as part of the drug registration process and uses the information provided in the (R,S)-4-Amino-5-hexenoic acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a (R,S)-4-Amino-5-hexenoic acid 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 (R,S)-4-Amino-5-hexenoic acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of (R,S)-4-Amino-5-hexenoic acid suppliers with KDMF on PharmaCompass.