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01 1Fermion Oy
02 1Cambrex Profarmaco Milano S. r. l.
03 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
01 2Alprazolam
02 1Japanese Pharmacopoeia alprazolam production dedicated
01 1Finland
02 1Japan
03 1U.S.A
Registration Number : 219MF10128
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2007-04-18
Latest Date of Registration : 2023-09-20
Registration Number : 218MF10715
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2006-08-14
Latest Date of Registration : 2018-11-20
Japanese Pharmacopoeia Alprazolam For manufacturing only
Registration Number : 217MF10394
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2005-08-10
Latest Date of Registration : 2009-07-30
A Ksalol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ksalol, including repackagers and relabelers. The FDA regulates Ksalol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ksalol 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 Ksalol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ksalol supplier is an individual or a company that provides Ksalol active pharmaceutical ingredient (API) or Ksalol finished formulations upon request. The Ksalol suppliers may include Ksalol API manufacturers, exporters, distributors and traders.
click here to find a list of Ksalol 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 Ksalol Drug Master File in Japan (Ksalol JDMF) empowers Ksalol 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 Ksalol JDMF during the approval evaluation for pharmaceutical products. At the time of Ksalol 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 Ksalol suppliers with JDMF on PharmaCompass.
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