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