X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
21
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 PREVALITE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PREVALITE, including repackagers and relabelers. The FDA regulates PREVALITE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PREVALITE 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 PREVALITE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PREVALITE supplier is an individual or a company that provides PREVALITE active pharmaceutical ingredient (API) or PREVALITE finished formulations upon request. The PREVALITE suppliers may include PREVALITE API manufacturers, exporters, distributors and traders.
click here to find a list of PREVALITE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PREVALITE DMF (Drug Master File) is a document detailing the whole manufacturing process of PREVALITE active pharmaceutical ingredient (API) in detail. Different forms of PREVALITE DMFs exist exist since differing nations have different regulations, such as PREVALITE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PREVALITE DMF submitted to regulatory agencies in the US is known as a USDMF. PREVALITE USDMF includes data on PREVALITE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PREVALITE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PREVALITE 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 PREVALITE Drug Master File in Japan (PREVALITE JDMF) empowers PREVALITE 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 PREVALITE JDMF during the approval evaluation for pharmaceutical products. At the time of PREVALITE 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 PREVALITE suppliers with JDMF on PharmaCompass.
A PREVALITE CEP of the European Pharmacopoeia monograph is often referred to as a PREVALITE Certificate of Suitability (COS). The purpose of a PREVALITE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PREVALITE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PREVALITE to their clients by showing that a PREVALITE CEP has been issued for it. The manufacturer submits a PREVALITE CEP (COS) as part of the market authorization procedure, and it takes on the role of a PREVALITE CEP holder for the record. Additionally, the data presented in the PREVALITE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PREVALITE DMF.
A PREVALITE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PREVALITE 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 PREVALITE suppliers with CEP (COS) on PharmaCompass.
A PREVALITE written confirmation (PREVALITE WC) is an official document issued by a regulatory agency to a PREVALITE manufacturer, verifying that the manufacturing facility of a PREVALITE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PREVALITE APIs or PREVALITE finished pharmaceutical products to another nation, regulatory agencies frequently require a PREVALITE WC (written confirmation) as part of the regulatory process.
click here to find a list of PREVALITE 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 PREVALITE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PREVALITE 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 PREVALITE 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 PREVALITE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PREVALITE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PREVALITE suppliers with NDC on PharmaCompass.
PREVALITE 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 PREVALITE 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 PREVALITE GMP manufacturer or PREVALITE GMP API supplier for your needs.
A PREVALITE CoA (Certificate of Analysis) is a formal document that attests to PREVALITE's compliance with PREVALITE specifications and serves as a tool for batch-level quality control.
PREVALITE CoA mostly includes findings from lab analyses of a specific batch. For each PREVALITE 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.
PREVALITE may be tested according to a variety of international standards, such as European Pharmacopoeia (PREVALITE EP), PREVALITE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PREVALITE USP).
Market Place
