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List of Certificates of Suitability (CEPs) for Fluorouracil Active Pharmaceutical Ingredient issued by the EDQM and listed on PharmaCompass.com

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R1-CEP 2000-092 - Rev 07
Valid
Chemical
2021-07-16
611
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R1-CEP 2008-183 - Rev 00
Withdrawn by EDQM F...
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2014-10-31
2015-03-30
611
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R1-CEP 2000-033 - Rev 07
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2022-05-13
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R1-CEP 2005-113 - Rev 05
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2021-11-22
611
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  • SOLUTION;TOPICAL - 2%
  • SOLUTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CREAM;TOPICAL - 0.5%
  • CREAM;TOPICAL - 4%

Looking for 51-21-8 / Fluorouracil API manufacturers, exporters & distributors?

Fluorouracil manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Fluorouracil API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Fluorouracil manufacturer or Fluorouracil supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluorouracil manufacturer or Fluorouracil supplier.

PharmaCompass also assists you with knowing the Fluorouracil API Price utilized in the formulation of products. Fluorouracil API Price is not always fixed or binding as the Fluorouracil Price is obtained through a variety of data sources. The Fluorouracil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Fluorouracil

Synonyms

5-fluorouracil, 51-21-8, 5-fu, Fluoroplex, Efudex, Adrucil

Cas Number

51-21-8

Unique Ingredient Identifier (UNII)

U3P01618RT

About Fluorouracil

A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.

Fluorouracil Manufacturers

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.

Fluorouracil Suppliers

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.

Fluorouracil CEP

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.

Fluorouracil Manufacturers | Traders | Suppliers

Fluorouracil Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Fluorouracil

Get in contact with the supplier of your choice:

  1. IMCD Group
  2. NANTONG HAIERS PHARMACEUTICAL CO., LTD. CN 226400 Rudong
  3. Nantong Jinghua Pharmaceutical
  4. Teva Pharmaceutical Industries
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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