Synopsis
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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API Imports and Exports
Drugs in Development
Lead Product(s) : Frexalimab,Cholestyramine,Carbon
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Frexalimab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Multiple Sclerosis.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
November 21, 2023
Lead Product(s) :
Alirocumab,Atorvastatin,Simvastatin,Fluvastatin,Pravastatin,Lovastatin,Rosuvastatin Calcium,Ezetimibe,
Therapeutic Area :
Cardiology/Vascular Diseases Highest Development Status :
Phase III Partner/Sponsor/Collaborator :
Regeneron Pharmaceuticals Deal Size : Inapplicable Deal Type : Inapplicable
Details : Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
April 27, 2018
Lead Product(s) :
Alirocumab,Rosuvastatin Calcium,Atorvastatin,Simvastatin,Pravastatin,Lovastatin,Fluvastatin,Ezetimibe,
Therapeutic Area :
Cardiology/Vascular Diseases Highest Development Status :
Phase III Partner/Sponsor/Collaborator :
Regeneron Pharmaceuticals Deal Size : Inapplicable Deal Type : Inapplicable
Details : Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hypercholesterolemia.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
April 27, 2018
Lead Product(s) : Alirocumab,Ezetimibe,Cholestyramine,Fenofibrate,Omega-3,Niacin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Alirocumab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Hypercholesterolemia.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
September 07, 2016
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,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,Cholestyramine
Therapeutic Area : Nephrology
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 Kidney Diseases.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 11, 2010
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Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Taste Masking
Chewable & Orodispersible Aids
Parenteral
Direct Compression
Thickeners and Stabilizers
Solubilizers
Film Formers & Plasticizers
Disintegrants & Superdisintegrants
Coating Systems & Additives
Co-Processed Excipients
Emulsifying Agents
Topical
Rheology Modifiers
API Stability Enhancers
Granulation
Surfactant & Foaming Agents
Lubricants & Glidants
Controlled & Modified Release
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Cholestyramine 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 Cholestyramine manufacturer or Cholestyramine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cholestyramine manufacturer or Cholestyramine supplier.
PharmaCompass also assists you with knowing the Cholestyramine API Price utilized in the formulation of products. Cholestyramine API Price is not always fixed or binding as the Cholestyramine Price is obtained through a variety of data sources. The Cholestyramine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A QUESTRAN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of QUESTRAN, including repackagers and relabelers. The FDA regulates QUESTRAN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. QUESTRAN 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 QUESTRAN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A QUESTRAN supplier is an individual or a company that provides QUESTRAN active pharmaceutical ingredient (API) or QUESTRAN finished formulations upon request. The QUESTRAN suppliers may include QUESTRAN API manufacturers, exporters, distributors and traders.
click here to find a list of QUESTRAN suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A QUESTRAN DMF (Drug Master File) is a document detailing the whole manufacturing process of QUESTRAN active pharmaceutical ingredient (API) in detail. Different forms of QUESTRAN DMFs exist exist since differing nations have different regulations, such as QUESTRAN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A QUESTRAN DMF submitted to regulatory agencies in the US is known as a USDMF. QUESTRAN USDMF includes data on QUESTRAN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The QUESTRAN USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of QUESTRAN 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 QUESTRAN Drug Master File in Japan (QUESTRAN JDMF) empowers QUESTRAN 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 QUESTRAN JDMF during the approval evaluation for pharmaceutical products. At the time of QUESTRAN 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 QUESTRAN suppliers with JDMF on PharmaCompass.
A QUESTRAN CEP of the European Pharmacopoeia monograph is often referred to as a QUESTRAN Certificate of Suitability (COS). The purpose of a QUESTRAN CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of QUESTRAN EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of QUESTRAN to their clients by showing that a QUESTRAN CEP has been issued for it. The manufacturer submits a QUESTRAN CEP (COS) as part of the market authorization procedure, and it takes on the role of a QUESTRAN CEP holder for the record. Additionally, the data presented in the QUESTRAN CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the QUESTRAN DMF.
A QUESTRAN CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. QUESTRAN 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 QUESTRAN suppliers with CEP (COS) on PharmaCompass.
A QUESTRAN written confirmation (QUESTRAN WC) is an official document issued by a regulatory agency to a QUESTRAN manufacturer, verifying that the manufacturing facility of a QUESTRAN active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting QUESTRAN APIs or QUESTRAN finished pharmaceutical products to another nation, regulatory agencies frequently require a QUESTRAN WC (written confirmation) as part of the regulatory process.
click here to find a list of QUESTRAN 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 QUESTRAN as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for QUESTRAN 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 QUESTRAN 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 QUESTRAN and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a QUESTRAN NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of QUESTRAN suppliers with NDC on PharmaCompass.
QUESTRAN 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 QUESTRAN 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 QUESTRAN GMP manufacturer or QUESTRAN GMP API supplier for your needs.
A QUESTRAN CoA (Certificate of Analysis) is a formal document that attests to QUESTRAN's compliance with QUESTRAN specifications and serves as a tool for batch-level quality control.
QUESTRAN CoA mostly includes findings from lab analyses of a specific batch. For each QUESTRAN 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.
QUESTRAN may be tested according to a variety of international standards, such as European Pharmacopoeia (QUESTRAN EP), QUESTRAN JP (Japanese Pharmacopeia) and the US Pharmacopoeia (QUESTRAN USP).
