01 1Ranke Quimica S. A.
01 1Aclidinium bromide
01 1Spain
Registration Number : 226MF10012
Registrant's Address : General Miter, 151, 08022 Barcelona, Spain
Initial Date of Registration : 2014-01-08
Latest Date of Registration : 2023-01-11
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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.
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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.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Eklira Drug Master File in Japan (Eklira JDMF) empowers Eklira API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Eklira JDMF during the approval evaluation for pharmaceutical products. At the time of Eklira JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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