01 2Sicor Societa (') Italiana Corticosteroidi S. r. l.
01 1Beclomethasone propionate "Teva / low"
02 1Beclomethasone propionate (Teva)
01 2Italy
Beclomethasone propionate "Teva/Rho"
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 Beclomethasone Dipropionate Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Beclomethasone Dipropionate Monohydrate, including repackagers and relabelers. The FDA regulates Beclomethasone Dipropionate Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate supplier is an individual or a company that provides Beclomethasone Dipropionate Monohydrate active pharmaceutical ingredient (API) or Beclomethasone Dipropionate Monohydrate finished formulations upon request. The Beclomethasone Dipropionate Monohydrate suppliers may include Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate Drug Master File in Japan (Beclomethasone Dipropionate Monohydrate JDMF) empowers Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Beclomethasone Dipropionate Monohydrate 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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