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PharmaCompass offers a list of Fluocytosine 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 Fluocytosine manufacturer or Fluocytosine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluocytosine manufacturer or Fluocytosine supplier.
PharmaCompass also assists you with knowing the Fluocytosine API Price utilized in the formulation of products. Fluocytosine API Price is not always fixed or binding as the Fluocytosine Price is obtained through a variety of data sources. The Fluocytosine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fluocytosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluocytosine, including repackagers and relabelers. The FDA regulates Fluocytosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluocytosine 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 Fluocytosine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluocytosine supplier is an individual or a company that provides Fluocytosine active pharmaceutical ingredient (API) or Fluocytosine finished formulations upon request. The Fluocytosine suppliers may include Fluocytosine API manufacturers, exporters, distributors and traders.
click here to find a list of Fluocytosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluocytosine DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluocytosine active pharmaceutical ingredient (API) in detail. Different forms of Fluocytosine DMFs exist exist since differing nations have different regulations, such as Fluocytosine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluocytosine DMF submitted to regulatory agencies in the US is known as a USDMF. Fluocytosine USDMF includes data on Fluocytosine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluocytosine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluocytosine 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 Fluocytosine Drug Master File in Japan (Fluocytosine JDMF) empowers Fluocytosine 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 Fluocytosine JDMF during the approval evaluation for pharmaceutical products. At the time of Fluocytosine 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 Fluocytosine suppliers with JDMF on PharmaCompass.
A Fluocytosine CEP of the European Pharmacopoeia monograph is often referred to as a Fluocytosine Certificate of Suitability (COS). The purpose of a Fluocytosine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fluocytosine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fluocytosine to their clients by showing that a Fluocytosine CEP has been issued for it. The manufacturer submits a Fluocytosine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fluocytosine CEP holder for the record. Additionally, the data presented in the Fluocytosine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fluocytosine DMF.
A Fluocytosine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fluocytosine 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 Fluocytosine suppliers with CEP (COS) on PharmaCompass.
A Fluocytosine written confirmation (Fluocytosine WC) is an official document issued by a regulatory agency to a Fluocytosine manufacturer, verifying that the manufacturing facility of a Fluocytosine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fluocytosine APIs or Fluocytosine finished pharmaceutical products to another nation, regulatory agencies frequently require a Fluocytosine WC (written confirmation) as part of the regulatory process.
click here to find a list of Fluocytosine suppliers with Written Confirmation (WC) 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 Fluocytosine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fluocytosine 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 Fluocytosine 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 Fluocytosine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluocytosine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fluocytosine suppliers with NDC on PharmaCompass.
Fluocytosine 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 Fluocytosine 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 Fluocytosine GMP manufacturer or Fluocytosine GMP API supplier for your needs.
A Fluocytosine CoA (Certificate of Analysis) is a formal document that attests to Fluocytosine's compliance with Fluocytosine specifications and serves as a tool for batch-level quality control.
Fluocytosine CoA mostly includes findings from lab analyses of a specific batch. For each Fluocytosine 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.
Fluocytosine may be tested according to a variety of international standards, such as European Pharmacopoeia (Fluocytosine EP), Fluocytosine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fluocytosine USP).