01 1IMCD SWITZERLAND AG Zürich CH
02 1NANTONG HAIERS PHARMACEUTICAL CO., LTD. Nantong CN
03 1NANTONG JINGHUA PHARMACEUTICAL CO., LTD. Nantong CN
04 1TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL
01 3Fluorouracil
02 1Fluorouracil, Micronised, non-micronised
01 2China
02 1Israel
03 1Netherlands
01 3Valid
02 1Withdrawn by EDQM Failure to CEP procedure
Fluorouracil, Micronised, Non-micronised
Certificate Number : R1-CEP 2000-092 - Rev 07
Status : Valid
Issue Date : 2021-07-16
Type : Chemical
Substance Number : 611
Certificate Number : R1-CEP 2008-183 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2014-10-31
Type : Chemical
Substance Number : 611
Certificate Number : R1-CEP 2000-033 - Rev 07
Status : Valid
Issue Date : 2022-05-13
Type : Chemical
Substance Number : 611
Certificate Number : R1-CEP 2005-113 - Rev 05
Status : Valid
Issue Date : 2021-11-22
Type : Chemical
Substance Number : 611
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.
A Fluorouracil CEP of the European Pharmacopoeia monograph is often referred to as a Fluorouracil Certificate of Suitability (COS). The purpose of a Fluorouracil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fluorouracil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fluorouracil to their clients by showing that a Fluorouracil CEP has been issued for it. The manufacturer submits a Fluorouracil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fluorouracil CEP holder for the record. Additionally, the data presented in the Fluorouracil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fluorouracil DMF.
A Fluorouracil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fluorouracil CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Fluorouracil suppliers with CEP (COS) on PharmaCompass.
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