Synopsis
0
KDMF
0
VMF
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
83
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 LOCHOLEST manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LOCHOLEST, including repackagers and relabelers. The FDA regulates LOCHOLEST manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LOCHOLEST 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 LOCHOLEST manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LOCHOLEST supplier is an individual or a company that provides LOCHOLEST active pharmaceutical ingredient (API) or LOCHOLEST finished formulations upon request. The LOCHOLEST suppliers may include LOCHOLEST API manufacturers, exporters, distributors and traders.
click here to find a list of LOCHOLEST suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LOCHOLEST DMF (Drug Master File) is a document detailing the whole manufacturing process of LOCHOLEST active pharmaceutical ingredient (API) in detail. Different forms of LOCHOLEST DMFs exist exist since differing nations have different regulations, such as LOCHOLEST USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LOCHOLEST DMF submitted to regulatory agencies in the US is known as a USDMF. LOCHOLEST USDMF includes data on LOCHOLEST's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LOCHOLEST USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LOCHOLEST 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 LOCHOLEST Drug Master File in Japan (LOCHOLEST JDMF) empowers LOCHOLEST 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 LOCHOLEST JDMF during the approval evaluation for pharmaceutical products. At the time of LOCHOLEST 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 LOCHOLEST suppliers with JDMF on PharmaCompass.
A LOCHOLEST CEP of the European Pharmacopoeia monograph is often referred to as a LOCHOLEST Certificate of Suitability (COS). The purpose of a LOCHOLEST CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LOCHOLEST EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LOCHOLEST to their clients by showing that a LOCHOLEST CEP has been issued for it. The manufacturer submits a LOCHOLEST CEP (COS) as part of the market authorization procedure, and it takes on the role of a LOCHOLEST CEP holder for the record. Additionally, the data presented in the LOCHOLEST CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LOCHOLEST DMF.
A LOCHOLEST CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LOCHOLEST 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 LOCHOLEST suppliers with CEP (COS) on PharmaCompass.
A LOCHOLEST written confirmation (LOCHOLEST WC) is an official document issued by a regulatory agency to a LOCHOLEST manufacturer, verifying that the manufacturing facility of a LOCHOLEST active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LOCHOLEST APIs or LOCHOLEST finished pharmaceutical products to another nation, regulatory agencies frequently require a LOCHOLEST WC (written confirmation) as part of the regulatory process.
click here to find a list of LOCHOLEST 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 LOCHOLEST as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LOCHOLEST 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 LOCHOLEST 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 LOCHOLEST and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LOCHOLEST NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LOCHOLEST suppliers with NDC on PharmaCompass.
LOCHOLEST 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 LOCHOLEST 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 LOCHOLEST GMP manufacturer or LOCHOLEST GMP API supplier for your needs.
A LOCHOLEST CoA (Certificate of Analysis) is a formal document that attests to LOCHOLEST's compliance with LOCHOLEST specifications and serves as a tool for batch-level quality control.
LOCHOLEST CoA mostly includes findings from lab analyses of a specific batch. For each LOCHOLEST 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.
LOCHOLEST may be tested according to a variety of international standards, such as European Pharmacopoeia (LOCHOLEST EP), LOCHOLEST JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LOCHOLEST USP).
