01 2Olon S. p. A.
02 1Sicor Societa (') Italiana Corticosteroidi S. r. l.
01 2Daunorubicin Hydrochloride
02 1Daunorubicin hydrochloride
01 3Italy
Registration Number : 221MF10078
Registrant's Address : Strada Rivoltana Km 6/7 20090 Rodano Milano Italy
Initial Date of Registration : 2009-04-14
Latest Date of Registration : 2010-02-16
Registration Number : 305MF10038
Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy
Initial Date of Registration : 2023-03-23
Latest Date of Registration : 2023-03-23
Registration Number : 306MF10068
Registrant's Address : Piazzale Luigi Cadorna, 4 - 20123 MILANO, Italy
Initial Date of Registration : 2024-05-15
Latest Date of Registration : 2024-05-15
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PharmaCompass offers a list of Daunorubicin HCl 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 Daunorubicin HCl manufacturer or Daunorubicin HCl supplier for your needs.
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A Daunorubicin HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daunorubicin HCl, including repackagers and relabelers. The FDA regulates Daunorubicin HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daunorubicin HCl 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 Daunorubicin HCl supplier is an individual or a company that provides Daunorubicin HCl active pharmaceutical ingredient (API) or Daunorubicin HCl finished formulations upon request. The Daunorubicin HCl suppliers may include Daunorubicin HCl 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 Daunorubicin HCl Drug Master File in Japan (Daunorubicin HCl JDMF) empowers Daunorubicin HCl 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 Daunorubicin HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Daunorubicin HCl 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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