01 1Sicor Societa (') Italiana Corticosteroidi S. r. l.
01 1Betamethasone acetate ester "Teva"
01 1Italy
Registration Number : 220MF10099
Registrant's Address : Piazzale Luigi Cadorna, 4 - 20123 MILANO, Italy
Initial Date of Registration : 2008-04-11
Latest Date of Registration : 2018-06-26
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PharmaCompass offers a list of Betamethasone Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Betamethasone Acetate manufacturer or Betamethasone Acetate supplier for your needs.
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A Betamethasone 21-acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betamethasone 21-acetate, including repackagers and relabelers. The FDA regulates Betamethasone 21-acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betamethasone 21-acetate 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 Betamethasone 21-acetate supplier is an individual or a company that provides Betamethasone 21-acetate active pharmaceutical ingredient (API) or Betamethasone 21-acetate finished formulations upon request. The Betamethasone 21-acetate suppliers may include Betamethasone 21-acetate 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 Betamethasone 21-acetate Drug Master File in Japan (Betamethasone 21-acetate JDMF) empowers Betamethasone 21-acetate 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 Betamethasone 21-acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Betamethasone 21-acetate 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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