Synopsis
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DRUG PRODUCT COMPOSITIONS0
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USDMF
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Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm : Plot No:4, Hetero Infrastructure SEZ Ltd.,Narasapuram, Visakhapatnam-531081, And...
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Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Inabata France, established in 1990 and part of the Inabata Group, acquired Pharmasynthèse in 2006. Today, Inabata-Pharmasynthèse offers sourcing, manufacturing, and development ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
About the Company : Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, leveraging the India advantage for global...
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API Imports and Exports
Drugs in Development
Lead Product(s) : Teriflunomide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The approval confirms Aubagio as the first oral multiple sclerosis (MS) therapy for first-line treatment of children and adolescents with MS in the European Union.
Product Name : Aubagio
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 18, 2021
Lead Product(s) : Teriflunomide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Rejects Aubagio sNDA for Pediatric Relapsing MS Indication
Details : Aubagio (teriflunomide) is an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase. It is being developed for the treatment of children and adolescents 10 to 17 years of age with relapsing forms of multiple scle...
Product Name : Aubagio
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 15, 2021
Lead Product(s) : Teriflunomide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Teriflunomide is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Multiple Sclerosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 01, 2020
Lead Product(s) : Teriflunomide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Teriflunomide is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Multiple Sclerosis, Relapsing-Remitting.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 27, 2019
Lead Product(s) : Teriflunomide,Colestipol
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Derrick Scott Robertson
Deal Size : Inapplicable
Deal Type : Inapplicable
Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride
Details : Teriflunomide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 13, 2014
Lead Product(s) : Teriflunomide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Teriflunomide is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Multiple Sclerosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 25, 2014
Lead Product(s) : Teriflunomide,Cholestyramine
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Teriflunomide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Multiple Sclerosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 28, 2014
Lead Product(s) : Teriflunomide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Teriflunomide is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Multiple Sclerosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 10, 2013
Lead Product(s) : Teriflunomide,Cholestyramine,Carbon
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis
Details : Teriflunomide is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Multiple Sclerosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 29, 2013
Lead Product(s) : Teriflunomide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
Details : Teriflunomide is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Multiple Sclerosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 07, 2011
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DOSAGE - TABLET;ORAL - 14MG
USFDA APPLICATION NUMBER - 202992
DOSAGE - TABLET;ORAL - 7MG
USFDA APPLICATION NUMBER - 202992
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ABOUT THIS PAGE
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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 Teriflunomide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teriflunomide, including repackagers and relabelers. The FDA regulates Teriflunomide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teriflunomide 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 Teriflunomide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Teriflunomide supplier is an individual or a company that provides Teriflunomide active pharmaceutical ingredient (API) or Teriflunomide finished formulations upon request. The Teriflunomide suppliers may include Teriflunomide API manufacturers, exporters, distributors and traders.
click here to find a list of Teriflunomide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Teriflunomide DMF (Drug Master File) is a document detailing the whole manufacturing process of Teriflunomide active pharmaceutical ingredient (API) in detail. Different forms of Teriflunomide DMFs exist exist since differing nations have different regulations, such as Teriflunomide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Teriflunomide DMF submitted to regulatory agencies in the US is known as a USDMF. Teriflunomide USDMF includes data on Teriflunomide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Teriflunomide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Teriflunomide suppliers with USDMF on PharmaCompass.
A Teriflunomide CEP of the European Pharmacopoeia monograph is often referred to as a Teriflunomide Certificate of Suitability (COS). The purpose of a Teriflunomide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Teriflunomide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Teriflunomide to their clients by showing that a Teriflunomide CEP has been issued for it. The manufacturer submits a Teriflunomide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Teriflunomide CEP holder for the record. Additionally, the data presented in the Teriflunomide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Teriflunomide DMF.
A Teriflunomide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Teriflunomide 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 Teriflunomide suppliers with CEP (COS) on PharmaCompass.
A Teriflunomide written confirmation (Teriflunomide WC) is an official document issued by a regulatory agency to a Teriflunomide manufacturer, verifying that the manufacturing facility of a Teriflunomide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Teriflunomide APIs or Teriflunomide finished pharmaceutical products to another nation, regulatory agencies frequently require a Teriflunomide WC (written confirmation) as part of the regulatory process.
click here to find a list of Teriflunomide 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 Teriflunomide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Teriflunomide 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 Teriflunomide 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 Teriflunomide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Teriflunomide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Teriflunomide suppliers with NDC on PharmaCompass.
Teriflunomide 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 Teriflunomide 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 Teriflunomide GMP manufacturer or Teriflunomide GMP API supplier for your needs.
A Teriflunomide CoA (Certificate of Analysis) is a formal document that attests to Teriflunomide's compliance with Teriflunomide specifications and serves as a tool for batch-level quality control.
Teriflunomide CoA mostly includes findings from lab analyses of a specific batch. For each Teriflunomide 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.
Teriflunomide may be tested according to a variety of international standards, such as European Pharmacopoeia (Teriflunomide EP), Teriflunomide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Teriflunomide USP).
