Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.
01 1Valsynthese SA
02 1Curia France S. A. S.
03 1DNP Fine Chemicals Utsunomiya Co., Ltd.
04 1Sanyo Chemical Research Institute Co., Ltd.
01 2Benzo phosphate succinate
02 1CIBENZOLINE SUCCINATE
03 1Cibenzoline succinate
01 1Gabon
02 1Japan
03 1Switzerland
04 1U.S.A
Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.
Cibenzoline succinate "Valsynthese"
Registration Number : 303MF10182
Registrant's Address : P. O. Box 636 Fabrikstrasse 48 3900 Brig, -Switzerland
Initial Date of Registration : 2021-12-15
Latest Date of Registration : 2021-12-15
Registration Number : 304MF10050
Registrant's Address : Zone industriale de Laville - 47240 Bon Encontre - France
Initial Date of Registration : 2022-03-10
Latest Date of Registration : 2022-03-10
Registration Number : 221MF10047
Registrant's Address : 1062-8 Honjo, Nishikata-cho, Tochigi City, Tochigi Prefecture
Initial Date of Registration : 2009-03-09
Latest Date of Registration : 2015-02-09
Registration Number : 225MF10211
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2013-11-20
Latest Date of Registration : 2013-11-20
A Cifenline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cifenline, including repackagers and relabelers. The FDA regulates Cifenline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cifenline 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 Cifenline supplier is an individual or a company that provides Cifenline active pharmaceutical ingredient (API) or Cifenline finished formulations upon request. The Cifenline suppliers may include Cifenline 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 Cifenline Drug Master File in Japan (Cifenline JDMF) empowers Cifenline 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 Cifenline JDMF during the approval evaluation for pharmaceutical products. At the time of Cifenline 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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