01 1Ranke Quimica, SA@[Partial process manufacturer] Ranke Quimica, SA (Planta Sant Celoni)@[Micro-pulverization process manufacturer] Catalent Micron Technologies Limited@[Micro-pulverization process manufacturer] Ranke Quimica, SA
01 1SPC Korea Co., Ltd.
01 1Aclidinium bromide
01 1Blank
Registrant Name : SPC Korea Co., Ltd.
Registration Date : 2014-06-30
Registration Number : Su4000-3-ND
Manufacturer Name : Ranke Quimica, SA@[Partial p...
Manufacturer Address : Carretera de Martorell 41-61, Sant Andreu de la Barca 08740 Barcelona, Spain@Ct...
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A Eklira manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eklira, including repackagers and relabelers. The FDA regulates Eklira manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eklira 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 Eklira manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Eklira supplier is an individual or a company that provides Eklira active pharmaceutical ingredient (API) or Eklira finished formulations upon request. The Eklira suppliers may include Eklira API manufacturers, exporters, distributors and traders.
click here to find a list of Eklira 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 Eklira Drug Master File in Korea (Eklira KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eklira. The MFDS reviews the Eklira KDMF as part of the drug registration process and uses the information provided in the Eklira KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eklira 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 Eklira API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eklira suppliers with KDMF on PharmaCompass.
