01 1Ajinomoto Co., Inc.
02 2Prime European Therapeuticals S. p. A. (Euticals S.p.A.)
03 1Yamasa Soy Sauce Co., Ltd.
01 1"Outsider Regulations" vidarabine (production only)
02 1Outsiders regulations vidarabine (production only)
03 1Vidarabine
04 1Vidarabine "Ajinomoto"
01 2Italy
02 2Japan
Registration Number : 217MF10300
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-06-30
Latest Date of Registration : 2010-03-23
Registration Number : 227MF10026
Registrant's Address : Viale Bianca Maria 25-20122 Milano-Italy
Initial Date of Registration : 2015-01-23
Latest Date of Registration : 2015-01-23
"Extra-official" vidarabine (for manufacturing purposes only)
Registration Number : 218MF10132
Registrant's Address : Viale Bianca Maria 25-20122 Milano-Italy
Initial Date of Registration : 2006-01-30
Latest Date of Registration : 2008-02-25
Extramural regulations Vidarabine (for manufacturing only)
Registration Number : 218MF10480
Registrant's Address : 2-10-1 Shinseicho, Choshi City, Chiba Prefecture
Initial Date of Registration : 2006-05-15
Latest Date of Registration : 2009-01-28
A Vidarabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vidarabine, including repackagers and relabelers. The FDA regulates Vidarabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vidarabine 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 Vidarabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vidarabine supplier is an individual or a company that provides Vidarabine active pharmaceutical ingredient (API) or Vidarabine finished formulations upon request. The Vidarabine suppliers may include Vidarabine API manufacturers, exporters, distributors and traders.
click here to find a list of Vidarabine 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 Vidarabine Drug Master File in Japan (Vidarabine JDMF) empowers Vidarabine 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 Vidarabine JDMF during the approval evaluation for pharmaceutical products. At the time of Vidarabine 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 Vidarabine suppliers with JDMF on PharmaCompass.
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