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AMI Lifesciences is Driven by Chemistry. Powered by People.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Cholestagel
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 625 mg
Packaging : Bottle of plastic
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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PharmaCompass offers a list of Colesevelam Hydrochloride 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 Colesevelam Hydrochloride manufacturer or Colesevelam Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Colesevelam Hydrochloride manufacturer or Colesevelam Hydrochloride supplier.
PharmaCompass also assists you with knowing the Colesevelam Hydrochloride API Price utilized in the formulation of products. Colesevelam Hydrochloride API Price is not always fixed or binding as the Colesevelam Hydrochloride Price is obtained through a variety of data sources. The Colesevelam Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Colesevelam Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colesevelam Hydrochloride, including repackagers and relabelers. The FDA regulates Colesevelam Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colesevelam Hydrochloride 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 Colesevelam Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Colesevelam Hydrochloride supplier is an individual or a company that provides Colesevelam Hydrochloride active pharmaceutical ingredient (API) or Colesevelam Hydrochloride finished formulations upon request. The Colesevelam Hydrochloride suppliers may include Colesevelam Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Colesevelam Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Colesevelam Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Colesevelam Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Colesevelam Hydrochloride DMFs exist exist since differing nations have different regulations, such as Colesevelam Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Colesevelam Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Colesevelam Hydrochloride USDMF includes data on Colesevelam Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Colesevelam Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Colesevelam Hydrochloride suppliers with USDMF on PharmaCompass.
A Colesevelam Hydrochloride written confirmation (Colesevelam Hydrochloride WC) is an official document issued by a regulatory agency to a Colesevelam Hydrochloride manufacturer, verifying that the manufacturing facility of a Colesevelam Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Colesevelam Hydrochloride APIs or Colesevelam Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Colesevelam Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Colesevelam Hydrochloride 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 Colesevelam Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Colesevelam Hydrochloride 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 Colesevelam Hydrochloride 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 Colesevelam Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Colesevelam Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Colesevelam Hydrochloride suppliers with NDC on PharmaCompass.
Colesevelam Hydrochloride 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 Colesevelam Hydrochloride 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 Colesevelam Hydrochloride GMP manufacturer or Colesevelam Hydrochloride GMP API supplier for your needs.
A Colesevelam Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Colesevelam Hydrochloride's compliance with Colesevelam Hydrochloride specifications and serves as a tool for batch-level quality control.
Colesevelam Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Colesevelam Hydrochloride 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.
Colesevelam Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Colesevelam Hydrochloride EP), Colesevelam Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Colesevelam Hydrochloride USP).
