In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 2-[2-(2,6-dichloroanilino)phenyl]acetic acid Drug Master File in Korea (2-[2-(2,6-dichloroanilino)phenyl]acetic acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 2-[2-(2,6-dichloroanilino)phenyl]acetic acid. The MFDS reviews the 2-[2-(2,6-dichloroanilino)phenyl]acetic acid KDMF as part of the drug registration process and uses the information provided in the 2-[2-(2,6-dichloroanilino)phenyl]acetic acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a 2-[2-(2,6-dichloroanilino)phenyl]acetic 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 2-[2-(2,6-dichloroanilino)phenyl]acetic acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 2-[2-(2,6-dichloroanilino)phenyl]acetic acid suppliers with KDMF on PharmaCompass.