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List of Drug Master Files (JDMF) for Fluorouracil Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Sanpo Chemical Research Institute Co., Ltd. (1)

02 Sicor de Me(´)xico,S. A. de C. V. (1)

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01 Fluorouracil "Teva 2" (1)

02 Japanese Pharmacopoeia fluorouracil (production only) (1)

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01 Japan (1)

02 Mexico (1)

URL Supplier Web Content
218MF10560
1-31 Jinnanbecho, Sakai-ku, Sakai-s...
2006-09-22
2006-06-02
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URL Supplier Web Content
227MF10172
Av. San Rafael No. 35 Parque Indust...
2015-06-26
2015-06-26
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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 JDMF

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.

Fluorouracil Manufacturers | Traders | Suppliers

Fluorouracil Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Fluorouracil

Get in contact with the supplier of your choice:

  1. Hosho Co
  2. Sicor de Mexico S.A. de C.V.
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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