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
A Aclidinium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aclidinium Bromide, including repackagers and relabelers. The FDA regulates Aclidinium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aclidinium Bromide 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 Aclidinium Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aclidinium Bromide supplier is an individual or a company that provides Aclidinium Bromide active pharmaceutical ingredient (API) or Aclidinium Bromide finished formulations upon request. The Aclidinium Bromide suppliers may include Aclidinium Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Aclidinium Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 Aclidinium Bromide Drug Master File in Japan (Aclidinium Bromide JDMF) empowers Aclidinium Bromide 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 Aclidinium Bromide JDMF during the approval evaluation for pharmaceutical products. At the time of Aclidinium Bromide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Aclidinium Bromide suppliers with JDMF on PharmaCompass.
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