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