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