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