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PharmaCompass offers a list of Rivaroxaban 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 Rivaroxaban manufacturer or Rivaroxaban supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rivaroxaban manufacturer or Rivaroxaban supplier.
PharmaCompass also assists you with knowing the Rivaroxaban API Price utilized in the formulation of products. Rivaroxaban API Price is not always fixed or binding as the Rivaroxaban Price is obtained through a variety of data sources. The Rivaroxaban Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Xarelto manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xarelto, including repackagers and relabelers. The FDA regulates Xarelto manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xarelto 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 Xarelto manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xarelto supplier is an individual or a company that provides Xarelto active pharmaceutical ingredient (API) or Xarelto finished formulations upon request. The Xarelto suppliers may include Xarelto API manufacturers, exporters, distributors and traders.
click here to find a list of Xarelto suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Xarelto DMF (Drug Master File) is a document detailing the whole manufacturing process of Xarelto active pharmaceutical ingredient (API) in detail. Different forms of Xarelto DMFs exist exist since differing nations have different regulations, such as Xarelto USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xarelto DMF submitted to regulatory agencies in the US is known as a USDMF. Xarelto USDMF includes data on Xarelto's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xarelto USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Xarelto suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Xarelto Drug Master File in Japan (Xarelto JDMF) empowers Xarelto API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Xarelto JDMF during the approval evaluation for pharmaceutical products. At the time of Xarelto JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Xarelto suppliers with JDMF 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 Xarelto Drug Master File in Korea (Xarelto KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xarelto. The MFDS reviews the Xarelto KDMF as part of the drug registration process and uses the information provided in the Xarelto KDMF to evaluate the safety and efficacy of the drug.
After submitting a Xarelto 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 Xarelto API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Xarelto suppliers with KDMF on PharmaCompass.
A Xarelto CEP of the European Pharmacopoeia monograph is often referred to as a Xarelto Certificate of Suitability (COS). The purpose of a Xarelto CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Xarelto EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Xarelto to their clients by showing that a Xarelto CEP has been issued for it. The manufacturer submits a Xarelto CEP (COS) as part of the market authorization procedure, and it takes on the role of a Xarelto CEP holder for the record. Additionally, the data presented in the Xarelto CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Xarelto DMF.
A Xarelto CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Xarelto 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 Xarelto suppliers with CEP (COS) on PharmaCompass.
A Xarelto written confirmation (Xarelto WC) is an official document issued by a regulatory agency to a Xarelto manufacturer, verifying that the manufacturing facility of a Xarelto active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Xarelto APIs or Xarelto finished pharmaceutical products to another nation, regulatory agencies frequently require a Xarelto WC (written confirmation) as part of the regulatory process.
click here to find a list of Xarelto 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 Xarelto as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Xarelto 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 Xarelto 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 Xarelto and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Xarelto NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Xarelto suppliers with NDC on PharmaCompass.
Xarelto 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 Xarelto 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 Xarelto GMP manufacturer or Xarelto GMP API supplier for your needs.
A Xarelto CoA (Certificate of Analysis) is a formal document that attests to Xarelto's compliance with Xarelto specifications and serves as a tool for batch-level quality control.
Xarelto CoA mostly includes findings from lab analyses of a specific batch. For each Xarelto 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.
Xarelto may be tested according to a variety of international standards, such as European Pharmacopoeia (Xarelto EP), Xarelto JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Xarelto USP).
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