01 1Olon SPA
01 1DKSH Korea Co., Ltd.
01 1Mefloquine hydrochloride
01 1Italy
Registrant Name : DKSH 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
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A Loriam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loriam, including repackagers and relabelers. The FDA regulates Loriam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loriam 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 Loriam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Loriam supplier is an individual or a company that provides Loriam active pharmaceutical ingredient (API) or Loriam finished formulations upon request. The Loriam suppliers may include Loriam API manufacturers, exporters, distributors and traders.
click here to find a list of Loriam suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Loriam Drug Master File in Korea (Loriam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Loriam. The MFDS reviews the Loriam KDMF as part of the drug registration process and uses the information provided in the Loriam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Loriam 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 Loriam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Loriam suppliers with KDMF on PharmaCompass.
