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