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API SUPPLIERS
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USDMF
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Fludara
Dosage Form : Fludarabine 50Mg 5 Units Parenteral Use
Dosage Strength : 5 vials groun EV 50 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Fludara
Dosage Form : Powder For Solution For Injection And Infusion
Dosage Strength : 25MG/ML
Packaging :
Approval Date : 2007-12-05
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Fludara
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2007-12-05
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Beneflur
Dosage Form : Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 08-07-2002
Application Number : 64900
Regulatory Info : Authorized
Registration Country : Spain
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Beneflur
Dosage Form : Powder For Injection And Infusion Solution
Dosage Strength : 50MG
Packaging :
Approval Date : 01-07-1995
Application Number : 60616
Regulatory Info : Cancelled
Registration Country : Spain
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Fludara
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 25-03-2002
Application Number : 28103264701
Regulatory Info : Prescription
Registration Country : Denmark
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Fludara
Dosage Form : Injection/Infusion Solution
Dosage Strength : 50mg
Packaging :
Approval Date : 27-01-1995
Application Number : 2.00E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Fludara
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 22-02-2002
Application Number : 2.00E+13
Regulatory Info : Approved
Registration Country : Sweden
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Fludara Oral
Dosage Form : FCT
Dosage Strength : 10mg
Packaging : 20X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Fludara
Dosage Form : POI
Dosage Strength : 50mg/2ml
Packaging : 10X5mg/2ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
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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, 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.
A FAMP manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of FAMP, including repackagers and relabelers. The FDA regulates FAMP manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. FAMP 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 FAMP manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A FAMP supplier is an individual or a company that provides FAMP active pharmaceutical ingredient (API) or FAMP finished formulations upon request. The FAMP suppliers may include FAMP API manufacturers, exporters, distributors and traders.
click here to find a list of FAMP suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A FAMP DMF (Drug Master File) is a document detailing the whole manufacturing process of FAMP active pharmaceutical ingredient (API) in detail. Different forms of FAMP DMFs exist exist since differing nations have different regulations, such as FAMP USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A FAMP DMF submitted to regulatory agencies in the US is known as a USDMF. FAMP USDMF includes data on FAMP's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The FAMP USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of FAMP suppliers with USDMF on PharmaCompass.
A FAMP CEP of the European Pharmacopoeia monograph is often referred to as a FAMP Certificate of Suitability (COS). The purpose of a FAMP CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of FAMP EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of FAMP to their clients by showing that a FAMP CEP has been issued for it. The manufacturer submits a FAMP CEP (COS) as part of the market authorization procedure, and it takes on the role of a FAMP CEP holder for the record. Additionally, the data presented in the FAMP CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the FAMP DMF.
A FAMP CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. FAMP 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 FAMP 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 FAMP as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for FAMP 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 FAMP 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 FAMP and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a FAMP NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of FAMP suppliers with NDC on PharmaCompass.
FAMP 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 FAMP GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right FAMP GMP manufacturer or FAMP GMP API supplier for your needs.
A FAMP CoA (Certificate of Analysis) is a formal document that attests to FAMP's compliance with FAMP specifications and serves as a tool for batch-level quality control.
FAMP CoA mostly includes findings from lab analyses of a specific batch. For each FAMP 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.
FAMP may be tested according to a variety of international standards, such as European Pharmacopoeia (FAMP EP), FAMP JP (Japanese Pharmacopeia) and the US Pharmacopoeia (FAMP USP).
