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