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