In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Anthranilic acid, N-(2,3-xylyl)- Drug Master File in Korea (Anthranilic acid, N-(2,3-xylyl)- KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Anthranilic acid, N-(2,3-xylyl)-. The MFDS reviews the Anthranilic acid, N-(2,3-xylyl)- KDMF as part of the drug registration process and uses the information provided in the Anthranilic acid, N-(2,3-xylyl)- KDMF to evaluate the safety and efficacy of the drug.
After submitting a Anthranilic acid, N-(2,3-xylyl)- 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 Anthranilic acid, N-(2,3-xylyl)- API can apply through the Korea Drug Master File (KDMF).
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