Synopsis
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CEP/COS
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Aspen API. More than just an API™
KDMF 
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
CA, ASMF
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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USDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15259
Submission : 2001-01-22
Status :
Type : II
Aspen API. More than just an API™
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28762
Submission : 2014-11-30
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-04
Pay. Date : 2022-03-29
DMF Number : 22579
Submission : 2009-02-26
Status :
Type : II
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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]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
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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 Arixtra manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arixtra, including repackagers and relabelers. The FDA regulates Arixtra manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Arixtra 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 Arixtra manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Arixtra supplier is an individual or a company that provides Arixtra active pharmaceutical ingredient (API) or Arixtra finished formulations upon request. The Arixtra suppliers may include Arixtra API manufacturers, exporters, distributors and traders.
click here to find a list of Arixtra suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Arixtra DMF (Drug Master File) is a document detailing the whole manufacturing process of Arixtra active pharmaceutical ingredient (API) in detail. Different forms of Arixtra DMFs exist exist since differing nations have different regulations, such as Arixtra USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Arixtra DMF submitted to regulatory agencies in the US is known as a USDMF. Arixtra USDMF includes data on Arixtra's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Arixtra USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Arixtra 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 Arixtra Drug Master File in Korea (Arixtra KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Arixtra. The MFDS reviews the Arixtra KDMF as part of the drug registration process and uses the information provided in the Arixtra KDMF to evaluate the safety and efficacy of the drug.
After submitting a Arixtra 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 Arixtra API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Arixtra suppliers with KDMF on PharmaCompass.
A Arixtra written confirmation (Arixtra WC) is an official document issued by a regulatory agency to a Arixtra manufacturer, verifying that the manufacturing facility of a Arixtra active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Arixtra APIs or Arixtra finished pharmaceutical products to another nation, regulatory agencies frequently require a Arixtra WC (written confirmation) as part of the regulatory process.
click here to find a list of Arixtra 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 Arixtra as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Arixtra 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 Arixtra 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 Arixtra and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Arixtra NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Arixtra suppliers with NDC on PharmaCompass.
Arixtra 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 Arixtra 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 Arixtra GMP manufacturer or Arixtra GMP API supplier for your needs.
A Arixtra CoA (Certificate of Analysis) is a formal document that attests to Arixtra's compliance with Arixtra specifications and serves as a tool for batch-level quality control.
Arixtra CoA mostly includes findings from lab analyses of a specific batch. For each Arixtra 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.
Arixtra may be tested according to a variety of international standards, such as European Pharmacopoeia (Arixtra EP), Arixtra JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Arixtra USP).
