01 1Asahi Kasei Finechem Corporation
02 1Yamasa Soy Sauce Co., Ltd.
01 1Cytarabine ocfosfate "Yamasa"
02 1Japanese Pharmacopoeia cytarabine (production only)
01 2Japan
Japanese Pharmacopoeia Cytarabine (for manufacturing purposes only)
Registration Number : 217MF10811
Registrant's Address : 3-3-23 Nakanoshima, Kita-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2007-08-01
Cytarabine ocphosphonate "Yamasa"
Registration Number : 218MF10475
Registrant's Address : 2-10-1 Shinsei-cho, Choshi City, Chiba Prefecture
Initial Date of Registration : 2006-05-15
Latest Date of Registration : 2009-01-28
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A 1-(b-D-Arabinofuranosyl)cytosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-(b-D-Arabinofuranosyl)cytosine, including repackagers and relabelers. The FDA regulates 1-(b-D-Arabinofuranosyl)cytosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-(b-D-Arabinofuranosyl)cytosine 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 1-(b-D-Arabinofuranosyl)cytosine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 1-(b-D-Arabinofuranosyl)cytosine supplier is an individual or a company that provides 1-(b-D-Arabinofuranosyl)cytosine active pharmaceutical ingredient (API) or 1-(b-D-Arabinofuranosyl)cytosine finished formulations upon request. The 1-(b-D-Arabinofuranosyl)cytosine suppliers may include 1-(b-D-Arabinofuranosyl)cytosine API manufacturers, exporters, distributors and traders.
click here to find a list of 1-(b-D-Arabinofuranosyl)cytosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 1-(b-D-Arabinofuranosyl)cytosine Drug Master File in Japan (1-(b-D-Arabinofuranosyl)cytosine JDMF) empowers 1-(b-D-Arabinofuranosyl)cytosine 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 1-(b-D-Arabinofuranosyl)cytosine JDMF during the approval evaluation for pharmaceutical products. At the time of 1-(b-D-Arabinofuranosyl)cytosine 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 1-(b-D-Arabinofuranosyl)cytosine suppliers with JDMF on PharmaCompass.
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