Synopsis
0
CEP/COS
0
JDMF
0
VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
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 : 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 : Italy
Brand Name : Arixtra
Dosage Form : Fondaparinux 7,5Mg 0,6Ml 10 Units Parenteral Use
Dosage Strength : 10 SYRINGES SC 7.5 mg 0.6 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 : 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 : 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 : 5 mg/0.4 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 : Prescription
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 : Prescription
Registration Country : Canada
Regulatory Info : Prescription
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 : Prescription
Registration Country : Canada
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : FONDAPARINUX SODIUM INJECTION
Dosage Form : SOLUTION
Dosage Strength : 2.5MG/0.5ML
Packaging : 10 PRE-FILLED SYRINGES
Approval Date :
Application Number : 2406853
Regulatory Info : Prescription
Registration Country : Canada
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : FONDAPARINUX SODIUM INJECTION
Dosage Form : SOLUTION
Dosage Strength : 7.5MG/0.6ML
Packaging : 10 PRE-FILLED SYRINGES
Approval Date :
Application Number : 2406896
Regulatory Info : Prescription
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Arixtra
Dosage Form :
Dosage Strength :
Packaging : 2
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Arixtra 2,5 mg/0,5 ml
Dosage Form : INJ
Dosage Strength : 2.5mg/0.5ml
Packaging : 0.5X10mg/0.5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Arixtra 5,0mg/0,4ml
Dosage Form : INJ
Dosage Strength : 5mg/0.4ml
Packaging : 0.4X10mg/0.4ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Arixtra 7,5mg/0,6ml
Dosage Form : INJ
Dosage Strength : 7.5mg/0.6ml
Packaging : 0.6X10mg/0.6ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Arixtra 10,0mg/0,8ml
Dosage Form : INJ
Dosage Strength : 10mg/0.8ml
Packaging : 0.8X10mg/0.8ml
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]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
Related Excipient Companies
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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
37
PharmaCompass offers a list of Fondaparinux Sodium 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 Fondaparinux Sodium manufacturer or Fondaparinux Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fondaparinux Sodium manufacturer or Fondaparinux Sodium supplier.
PharmaCompass also assists you with knowing the Fondaparinux Sodium API Price utilized in the formulation of products. Fondaparinux Sodium API Price is not always fixed or binding as the Fondaparinux Sodium Price is obtained through a variety of data sources. The Fondaparinux Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fondaparinux manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fondaparinux, including repackagers and relabelers. The FDA regulates Fondaparinux manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fondaparinux 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fondaparinux supplier is an individual or a company that provides Fondaparinux active pharmaceutical ingredient (API) or Fondaparinux finished formulations upon request. The Fondaparinux suppliers may include Fondaparinux API manufacturers, exporters, distributors and traders.
click here to find a list of Fondaparinux suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fondaparinux DMF (Drug Master File) is a document detailing the whole manufacturing process of Fondaparinux active pharmaceutical ingredient (API) in detail. Different forms of Fondaparinux DMFs exist exist since differing nations have different regulations, such as Fondaparinux USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fondaparinux DMF submitted to regulatory agencies in the US is known as a USDMF. Fondaparinux USDMF includes data on Fondaparinux's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fondaparinux USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fondaparinux 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 Drug Master File in Korea (Fondaparinux KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fondaparinux. The MFDS reviews the Fondaparinux KDMF as part of the drug registration process and uses the information provided in the Fondaparinux KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fondaparinux 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fondaparinux suppliers with KDMF on PharmaCompass.
A Fondaparinux written confirmation (Fondaparinux WC) is an official document issued by a regulatory agency to a Fondaparinux manufacturer, verifying that the manufacturing facility of a Fondaparinux active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fondaparinux APIs or Fondaparinux finished pharmaceutical products to another nation, regulatory agencies frequently require a Fondaparinux WC (written confirmation) as part of the regulatory process.
click here to find a list of Fondaparinux 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fondaparinux 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fondaparinux NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fondaparinux suppliers with NDC on PharmaCompass.
Fondaparinux 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 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 GMP manufacturer or Fondaparinux GMP API supplier for your needs.
A Fondaparinux CoA (Certificate of Analysis) is a formal document that attests to Fondaparinux's compliance with Fondaparinux specifications and serves as a tool for batch-level quality control.
Fondaparinux CoA mostly includes findings from lab analyses of a specific batch. For each Fondaparinux 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Fondaparinux EP), Fondaparinux JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fondaparinux USP).
