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JDMF
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EU WC
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS
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US Patents
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
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]Faran Shimi Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fludarabine, including repackagers and relabelers. The FDA regulates Fludarabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fludarabine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fludarabine supplier is an individual or a company that provides Fludarabine active pharmaceutical ingredient (API) or Fludarabine finished formulations upon request. The Fludarabine suppliers may include Fludarabine API manufacturers, exporters, distributors and traders.
click here to find a list of Fludarabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fludarabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Fludarabine active pharmaceutical ingredient (API) in detail. Different forms of Fludarabine DMFs exist exist since differing nations have different regulations, such as Fludarabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fludarabine DMF submitted to regulatory agencies in the US is known as a USDMF. Fludarabine USDMF includes data on Fludarabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fludarabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fludarabine suppliers with USDMF on PharmaCompass.
A Fludarabine CEP of the European Pharmacopoeia monograph is often referred to as a Fludarabine Certificate of Suitability (COS). The purpose of a Fludarabine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fludarabine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fludarabine to their clients by showing that a Fludarabine CEP has been issued for it. The manufacturer submits a Fludarabine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fludarabine CEP holder for the record. Additionally, the data presented in the Fludarabine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fludarabine DMF.
A Fludarabine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fludarabine 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 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fludarabine 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fludarabine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fludarabine suppliers with NDC on PharmaCompass.
Fludarabine 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 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 GMP manufacturer or Fludarabine GMP API supplier for your needs.
A Fludarabine CoA (Certificate of Analysis) is a formal document that attests to Fludarabine's compliance with Fludarabine specifications and serves as a tool for batch-level quality control.
Fludarabine CoA mostly includes findings from lab analyses of a specific batch. For each Fludarabine 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Fludarabine EP), Fludarabine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fludarabine USP).
