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