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List of Drug Master Files (DMF) of Fluorouracil Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Actylis (1)

02 Amcol (2)

03 Dolder AG (1)

04 Nantong Jinghua Pharmaceutical (1)

05 Pfanstiehl (1)

06 Teva API (1)

07 Blank (8)

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01 5-FLUORO-URACIL,PRODUCT 4965 (1)

02 5-FLUOROURACIL (5)

03 FLUOROURACIL (4)

04 FLUOROURACIL IN MICROSPONGE® POLYMER (FLUROURACIL IN METHYL METHACRYLATE/DIMETHACRYLATE CROSSPOLYMER) (1)

05 FLUOROURACIL USP (1)

06 FTORAFUR (1-TETRAHYDRO-2-FURANYL) 5-FLUOROURACIL) PROD CODE #F-107 (1)

07 POLY-PORE® FLUOROURACIL POLYMER (1)

08 STERILE PROCESSING FACILITY IN NEW MEXICO (1)

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01 China (1)

02 Israel (1)

03 Switzerland (1)

04 U.S.A (4)

05 Blank (8)

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01 Active (5)

02 Inactive (10)

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01 Complete (4)

02 Blank (11)

URL Supplier Web Content
4959
Inactive
1983-05-18
N/A
II
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URL Supplier Web Content
29443
Active
2015-11-13
Complete
2017-07-07
2015-07-08
II
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URL Supplier Web Content
12738
Active
1997-11-11
N/A
II
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URL Supplier Web Content
21774
Active
2008-06-30
Complete
2014-06-16
2014-05-20
II
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URL Supplier Web Content
18478
Active
2005-06-28
Complete
2020-05-06
2020-04-29
II
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URL Supplier Web Content
4247
Inactive
1981-07-21
N/A
II
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URL Supplier Web Content
3062
Active
1977-11-09
Complete
2012-11-30
2012-11-08
II
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HEINRICH MACK NACHF

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2892
Inactive
1977-03-08
N/A
II
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ANDARD MOUNT INTERNATIONAL LTD

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6098
Inactive
1985-10-23
N/A
II
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INTERNATL CHEM & NUCLEAR PHARMS INC

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1138
Inactive
1968-02-02
N/A
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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 USDMF

A Fluorouracil DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluorouracil active pharmaceutical ingredient (API) in detail. Different forms of Fluorouracil DMFs exist exist since differing nations have different regulations, such as Fluorouracil USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Fluorouracil DMF submitted to regulatory agencies in the US is known as a USDMF. Fluorouracil USDMF includes data on Fluorouracil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluorouracil USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Fluorouracil suppliers with USDMF on PharmaCompass.

Fluorouracil Manufacturers | Traders | Suppliers

Fluorouracil Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Fluorouracil

Get in contact with the supplier of your choice:

  1. Actylis
  2. Amcol
  3. Dolder AG
  4. Nantong Jinghua Pharmaceutical
  5. Pfanstiehl
  6. Teva API
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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