01 2Sicor Societa (') Italiana Corticosteroidi S. r. l.
01 1Beclomethasone propionate "Teva / low"
02 1Beclomethasone propionate (Teva)
01 2Italy
Beclomethasone propionate "Teva/Law"
Registration Number : 218MF10626
Registrant's Address : Piazzale Luigi Cadorna, 4 - 20123 MILANO, Italy
Initial Date of Registration : 2006-07-20
Latest Date of Registration : 2006-07-20
Beclomethasone dipropionate (Teva)
Registration Number : 218MF10532
Registrant's Address : Piazzale Luigi Cadorna, 4-20123 MILANO, Italy
Initial Date of Registration : 2006-06-01
Latest Date of Registration : 2006-06-01
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A Orion Brand of Beclomethasone Dipropionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orion Brand of Beclomethasone Dipropionate, including repackagers and relabelers. The FDA regulates Orion Brand of Beclomethasone Dipropionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orion Brand of Beclomethasone Dipropionate 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 Orion Brand of Beclomethasone Dipropionate supplier is an individual or a company that provides Orion Brand of Beclomethasone Dipropionate active pharmaceutical ingredient (API) or Orion Brand of Beclomethasone Dipropionate finished formulations upon request. The Orion Brand of Beclomethasone Dipropionate suppliers may include Orion Brand of Beclomethasone Dipropionate 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 Orion Brand of Beclomethasone Dipropionate Drug Master File in Japan (Orion Brand of Beclomethasone Dipropionate JDMF) empowers Orion Brand of Beclomethasone Dipropionate 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 Orion Brand of Beclomethasone Dipropionate JDMF during the approval evaluation for pharmaceutical products. At the time of Orion Brand of Beclomethasone Dipropionate 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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