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