US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Apixaban 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 Apixaban manufacturer or Apixaban supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Apixaban manufacturer or Apixaban supplier.
PharmaCompass also assists you with knowing the Apixaban API Price utilized in the formulation of products. Apixaban API Price is not always fixed or binding as the Apixaban Price is obtained through a variety of data sources. The Apixaban Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Apixaban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apixaban, including repackagers and relabelers. The FDA regulates Apixaban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apixaban API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Apixaban supplier is an individual or a company that provides Apixaban active pharmaceutical ingredient (API) or Apixaban finished formulations upon request. The Apixaban suppliers may include Apixaban API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Apixaban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Apixaban DMF (Drug Master File) is a document detailing the whole manufacturing process of Apixaban active pharmaceutical ingredient (API) in detail. Different forms of Apixaban DMFs exist exist since differing nations have different regulations, such as Apixaban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apixaban DMF submitted to regulatory agencies in the US is known as a USDMF. Apixaban USDMF includes data on Apixaban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apixaban USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Apixaban Drug Master File in Korea (Apixaban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Apixaban. The MFDS reviews the Apixaban KDMF as part of the drug registration process and uses the information provided in the Apixaban KDMF to evaluate the safety and efficacy of the drug.
After submitting a Apixaban 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 Apixaban API can apply through the Korea Drug Master File (KDMF).
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A Apixaban written confirmation (Apixaban WC) is an official document issued by a regulatory agency to a Apixaban manufacturer, verifying that the manufacturing facility of a Apixaban active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Apixaban APIs or Apixaban finished pharmaceutical products to another nation, regulatory agencies frequently require a Apixaban WC (written confirmation) as part of the regulatory process.
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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 Apixaban as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Apixaban 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 Apixaban 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 Apixaban and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Apixaban NDC to their finished compounded human drug products, they may choose to do so.
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Apixaban 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 Apixaban 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 Apixaban GMP manufacturer or Apixaban GMP API supplier for your needs.
A Apixaban CoA (Certificate of Analysis) is a formal document that attests to Apixaban's compliance with Apixaban specifications and serves as a tool for batch-level quality control.
Apixaban CoA mostly includes findings from lab analyses of a specific batch. For each Apixaban 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.
Apixaban may be tested according to a variety of international standards, such as European Pharmacopoeia (Apixaban EP), Apixaban JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Apixaban USP).