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