Synopsis
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CEP/COS
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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API Imports and Exports
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Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Sweden
Brand Name : Arixtra
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 2.5 MG / 0.5 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Italy
Brand Name : Arixtra
Dosage Form : Fondaparinux 10Mg 0,8Ml 10 Units Parenteral Use
Dosage Strength : 10 SYRINGES SC 10 mg 0.8 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Italy
Brand Name : Arixtra
Dosage Form : Fondaparinux 2,5Mg 0,5Ml 10 Inita' Parenteral Use
Dosage Strength : 10 SYRINGES SC 2.5 mg 0.5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Italy
Brand Name : Arixtra
Dosage Form : Fondaparinux 5Mg 0.4 Ml 10 Units Parenteral Use
Dosage Strength : 10 SYRINGES SC 5 mg 0.4 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Norway
Brand Name : Arixtra
Dosage Form : Injection fluid, resolution
Dosage Strength : 10 mg/0.8 ml
Packaging : Finish filled syringe
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Norway
Brand Name : Arixtra
Dosage Form : Injection fluid, resolution
Dosage Strength : 2.5 mg/0.5 ml
Packaging : Finish filled syringe
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Norway
Brand Name : Arixtra
Dosage Form : Injection fluid, resolution
Dosage Strength : 2.5 mg/0.5 ml
Packaging : Finish filled syringe
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Norway
Brand Name : Arixtra
Dosage Form : Injection fluid, resolution
Dosage Strength : 2.5 mg/0.5 ml
Packaging : Finish filled syringe
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Norway
Brand Name : Arixtra
Dosage Form : Injection fluid, resolution
Dosage Strength : 5 mg/0.4 ml
Packaging : Finish filled syringe
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Norway
Brand Name : Arixtra
Dosage Form : Injection fluid, resolution
Dosage Strength : 7.5 mg/0.6 ml
Packaging : Finish filled syringe
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info :
Registration Country : Canada
Brand Name : ARIXTRA
Dosage Form : SOLUTION
Dosage Strength : 2.5MG/0.5ML
Packaging : 0.5ML
Approval Date :
Application Number : 2245531
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : ARIXTRA
Dosage Form : SOLUTION
Dosage Strength : 7.5MG/0.6ML
Packaging : 0.6ML
Approval Date :
Application Number : 2258056
Regulatory Info :
Registration Country : 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]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 2.5MG/0.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5MG/0.4ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 7.5MG/0.6ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10MG/0.8ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;SUBCUTANEOUS - 10MG/0.8ML
USFDA APPLICATION NUMBER - 21345
DOSAGE - INJECTABLE;SUBCUTANEOUS - 2.5MG/0.5M...DOSAGE - INJECTABLE;SUBCUTANEOUS - 2.5MG/0.5ML
USFDA APPLICATION NUMBER - 21345
DOSAGE - INJECTABLE;SUBCUTANEOUS - 5MG/0.4ML
USFDA APPLICATION NUMBER - 21345
DOSAGE - INJECTABLE;SUBCUTANEOUS - 7.5MG/0.6M...DOSAGE - INJECTABLE;SUBCUTANEOUS - 7.5MG/0.6ML
USFDA APPLICATION NUMBER - 21345
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Digital Content
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Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finished Drug Prices
Aspen API. More than just an API.
RX/OTC/DISCN : Class A
Dosage Form : Fondaparinux 1,5Mg 0,3Ml 10 Unit...
Dosage Strength : 10 SYRINGES SC 1.5 mg 0.3 ml
Price Per Pack (Euro) : 40.47
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Aspen API. More than just an API.
RX/OTC/DISCN : Class A
Dosage Form : Fondaparinux 10Mg 0,8Ml 10 Units...
Dosage Strength : 10 SYRINGES SC 10 mg 0.8 ml
Price Per Pack (Euro) : 207.01
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Aspen API. More than just an API.
RX/OTC/DISCN : Class A
Dosage Form : Fondaparinux 2,5Mg 0,5Ml 10 Init...
Dosage Strength : 10 SYRINGES SC 2.5 mg 0.5 ml
Price Per Pack (Euro) : 67.45
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Aspen API. More than just an API.
RX/OTC/DISCN : Class A
Dosage Form : Fondaparinux 5Mg 0.4 Ml 10 Units...
Dosage Strength : 10 SYRINGES SC 5 mg 0.4 ml
Price Per Pack (Euro) : 138.04
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Aspen API. More than just an API.
RX/OTC/DISCN : Class A
Dosage Form : Fondaparinux 7,5Mg 0,6Ml 10 Unit...
Dosage Strength : 10 SYRINGES SC 7.5 mg 0.6 ml
Price Per Pack (Euro) : 207.01
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Aspen API. More than just an API.
RX/OTC/DISCN :
Dosage Form : Injection fluid, resolution
Dosage Strength : 10 mg/0.8 ml
Price Per Pack (Euro) : 38.61
Published in :
Country : Norway
RX/OTC/DISCN :
Aspen API. More than just an API.
RX/OTC/DISCN :
Dosage Form : Injection fluid, resolution
Dosage Strength : 10 mg/0.8 ml
Price Per Pack (Euro) : 123.27
Published in :
Country : Norway
RX/OTC/DISCN :
Aspen API. More than just an API.
RX/OTC/DISCN :
Dosage Form : Injection fluid, resolution
Dosage Strength : 10 mg/0.8 ml
Price Per Pack (Euro) : 174.06
Published in :
Country : Norway
RX/OTC/DISCN :
Aspen API. More than just an API.
RX/OTC/DISCN :
Dosage Form : Injection fluid, resolution
Dosage Strength : 2.5 mg/0.5 ml
Price Per Pack (Euro) : 14.179
Published in :
Country : Norway
RX/OTC/DISCN :
Aspen API. More than just an API.
RX/OTC/DISCN :
Dosage Form : Injection fluid, resolution
Dosage Strength : 2.5 mg/0.5 ml
Price Per Pack (Euro) : 40.667
Published in :
Country : Norway
RX/OTC/DISCN :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Fondaparinux Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fondaparinux Sodium, including repackagers and relabelers. The FDA regulates Fondaparinux Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fondaparinux Sodium 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 Fondaparinux Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fondaparinux Sodium supplier is an individual or a company that provides Fondaparinux Sodium active pharmaceutical ingredient (API) or Fondaparinux Sodium finished formulations upon request. The Fondaparinux Sodium suppliers may include Fondaparinux Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Fondaparinux Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fondaparinux Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Fondaparinux Sodium active pharmaceutical ingredient (API) in detail. Different forms of Fondaparinux Sodium DMFs exist exist since differing nations have different regulations, such as Fondaparinux Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fondaparinux Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Fondaparinux Sodium USDMF includes data on Fondaparinux Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fondaparinux Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fondaparinux Sodium suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Fondaparinux Sodium Drug Master File in Korea (Fondaparinux Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fondaparinux Sodium. The MFDS reviews the Fondaparinux Sodium KDMF as part of the drug registration process and uses the information provided in the Fondaparinux Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fondaparinux Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Fondaparinux Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fondaparinux Sodium suppliers with KDMF on PharmaCompass.
A Fondaparinux Sodium written confirmation (Fondaparinux Sodium WC) is an official document issued by a regulatory agency to a Fondaparinux Sodium manufacturer, verifying that the manufacturing facility of a Fondaparinux Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fondaparinux Sodium APIs or Fondaparinux Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Fondaparinux Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Fondaparinux Sodium 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 Fondaparinux Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fondaparinux Sodium 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 Fondaparinux Sodium 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 Fondaparinux Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fondaparinux Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fondaparinux Sodium suppliers with NDC on PharmaCompass.
Fondaparinux Sodium 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 Fondaparinux Sodium 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 Fondaparinux Sodium GMP manufacturer or Fondaparinux Sodium GMP API supplier for your needs.
A Fondaparinux Sodium CoA (Certificate of Analysis) is a formal document that attests to Fondaparinux Sodium's compliance with Fondaparinux Sodium specifications and serves as a tool for batch-level quality control.
Fondaparinux Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Fondaparinux Sodium 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.
Fondaparinux Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Fondaparinux Sodium EP), Fondaparinux Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fondaparinux Sodium USP).
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