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KDMF
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DRUG PRODUCT COMPOSITIONS
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API SUPPLIERS
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USDMF
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API Imports and Exports
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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 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).
