01 1Olon SPA
01 1DKS Korea Co., Ltd.
01 1Mefloquine hydrochloride
01 1Italy
Registrant Name : DKS Korea Co., Ltd.
Registration Date : 2022-09-28
Registration Number : 20220928-209-J-1371
Manufacturer Name : Olon SPA
Manufacturer Address : VIA LIVELLI, 1(loc. FRAZIONE MAIRANO) - 26852 CASALETTO LODIGIANO (LO), Italy
A Mefloquine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mefloquine, including repackagers and relabelers. The FDA regulates Mefloquine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mefloquine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Mefloquine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mefloquine supplier is an individual or a company that provides Mefloquine active pharmaceutical ingredient (API) or Mefloquine finished formulations upon request. The Mefloquine suppliers may include Mefloquine API manufacturers, exporters, distributors and traders.
click here to find a list of Mefloquine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Mefloquine Drug Master File in Korea (Mefloquine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mefloquine. The MFDS reviews the Mefloquine KDMF as part of the drug registration process and uses the information provided in the Mefloquine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mefloquine 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 Mefloquine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mefloquine suppliers with KDMF on PharmaCompass.
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