Synopsis
0
EU WC
0
KDMF
0
VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;TOPICAL - 2%
USFDA APPLICATION NUMBER - 16831
DOSAGE - SOLUTION;TOPICAL - 5% **Federal Regi...DOSAGE - SOLUTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16831
DOSAGE - CREAM;TOPICAL - 0.5%
USFDA APPLICATION NUMBER - 20985
DOSAGE - CREAM;TOPICAL - 4%
USFDA APPLICATION NUMBER - 22259
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]BioSpectra
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lubrizol Life Science Health
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Solubilizers
Parenteral
Film Formers & Plasticizers
Thickeners and Stabilizers
Emulsifying Agents
Fillers, Diluents & Binders
Coating Systems & Additives
Surfactant & Foaming Agents
Co-Processed Excipients
Direct Compression
Lubricants & Glidants
Rheology Modifiers
Granulation
Controlled & Modified Release
API Stability Enhancers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
22
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.
A ICN Brand of Fluorouracil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ICN Brand of Fluorouracil, including repackagers and relabelers. The FDA regulates ICN Brand of Fluorouracil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ICN Brand of 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 ICN Brand of Fluorouracil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ICN Brand of Fluorouracil supplier is an individual or a company that provides ICN Brand of Fluorouracil active pharmaceutical ingredient (API) or ICN Brand of Fluorouracil finished formulations upon request. The ICN Brand of Fluorouracil suppliers may include ICN Brand of Fluorouracil API manufacturers, exporters, distributors and traders.
click here to find a list of ICN Brand of Fluorouracil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ICN Brand of Fluorouracil DMF (Drug Master File) is a document detailing the whole manufacturing process of ICN Brand of Fluorouracil active pharmaceutical ingredient (API) in detail. Different forms of ICN Brand of Fluorouracil DMFs exist exist since differing nations have different regulations, such as ICN Brand of Fluorouracil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ICN Brand of Fluorouracil DMF submitted to regulatory agencies in the US is known as a USDMF. ICN Brand of Fluorouracil USDMF includes data on ICN Brand of Fluorouracil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ICN Brand of Fluorouracil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ICN Brand of Fluorouracil suppliers with USDMF 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 ICN Brand of Fluorouracil Drug Master File in Japan (ICN Brand of Fluorouracil JDMF) empowers ICN Brand of 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 ICN Brand of Fluorouracil JDMF during the approval evaluation for pharmaceutical products. At the time of ICN Brand 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 ICN Brand of Fluorouracil suppliers with JDMF on PharmaCompass.
A ICN Brand of Fluorouracil CEP of the European Pharmacopoeia monograph is often referred to as a ICN Brand of Fluorouracil Certificate of Suitability (COS). The purpose of a ICN Brand of Fluorouracil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ICN Brand of Fluorouracil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ICN Brand of Fluorouracil to their clients by showing that a ICN Brand of Fluorouracil CEP has been issued for it. The manufacturer submits a ICN Brand of Fluorouracil CEP (COS) as part of the market authorization procedure, and it takes on the role of a ICN Brand of Fluorouracil CEP holder for the record. Additionally, the data presented in the ICN Brand of Fluorouracil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ICN Brand of Fluorouracil DMF.
A ICN Brand of Fluorouracil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ICN Brand of 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 ICN Brand of Fluorouracil suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing ICN Brand of Fluorouracil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ICN Brand of Fluorouracil API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture ICN Brand of Fluorouracil as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain ICN Brand of Fluorouracil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ICN Brand of Fluorouracil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ICN Brand of Fluorouracil suppliers with NDC on PharmaCompass.
ICN Brand of Fluorouracil Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of ICN Brand of Fluorouracil GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right ICN Brand of Fluorouracil GMP manufacturer or ICN Brand of Fluorouracil GMP API supplier for your needs.
A ICN Brand of Fluorouracil CoA (Certificate of Analysis) is a formal document that attests to ICN Brand of Fluorouracil's compliance with ICN Brand of Fluorouracil specifications and serves as a tool for batch-level quality control.
ICN Brand of Fluorouracil CoA mostly includes findings from lab analyses of a specific batch. For each ICN Brand of Fluorouracil CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
ICN Brand of Fluorouracil may be tested according to a variety of international standards, such as European Pharmacopoeia (ICN Brand of Fluorouracil EP), ICN Brand of Fluorouracil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ICN Brand of Fluorouracil USP).
