01 1Sanbo Chemical Laboratory Co., Ltd.
02 1Sicor de Me(´)xico,S. A. de C. V.
01 1Fluorouracil "Teva 2"
02 1Japanese Pharmacopoeia fluorouracil (production only)
01 1Japan
02 1Mexico
Japanese Pharmacopoeia Fluorouracil (for manufacturing only)
Registration Number : 218MF10560
Registrant's Address : 1-31 Kannanbecho, Sakai-ku, Sakai-shi, Osaka
Initial Date of Registration : 2006-06-02
Latest Date of Registration : 2006-09-22
Registration Number : 227MF10172
Registrant's Address : Av. San Rafael No. 35 Parque Industrial Lerma, CP52000 Lerma, Edo. Me(´)xico. MEXICO
Initial Date of Registration : 2015-06-26
Latest Date of Registration : 2015-06-26
A Fluorouracil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluorouracil, including repackagers and relabelers. The FDA regulates Fluorouracil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluorouracil 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 Fluorouracil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluorouracil supplier is an individual or a company that provides Fluorouracil active pharmaceutical ingredient (API) or Fluorouracil finished formulations upon request. The Fluorouracil suppliers may include Fluorouracil API manufacturers, exporters, distributors and traders.
click here to find a list of Fluorouracil 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 Fluorouracil Drug Master File in Japan (Fluorouracil JDMF) empowers Fluorouracil 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 Fluorouracil JDMF during the approval evaluation for pharmaceutical products. At the time of Fluorouracil 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 Fluorouracil suppliers with JDMF on PharmaCompass.
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