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ABOUT THIS PAGE
A Crofelemer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Crofelemer, including repackagers and relabelers. The FDA regulates Crofelemer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Crofelemer API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Crofelemer supplier is an individual or a company that provides Crofelemer active pharmaceutical ingredient (API) or Crofelemer finished formulations upon request. The Crofelemer suppliers may include Crofelemer API manufacturers, exporters, distributors and traders.
click here to find a list of Crofelemer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Crofelemer written confirmation (Crofelemer WC) is an official document issued by a regulatory agency to a Crofelemer manufacturer, verifying that the manufacturing facility of a Crofelemer active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Crofelemer APIs or Crofelemer finished pharmaceutical products to another nation, regulatory agencies frequently require a Crofelemer WC (written confirmation) as part of the regulatory process.
click here to find a list of Crofelemer 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 Crofelemer as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Crofelemer 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 Crofelemer 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 Crofelemer and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Crofelemer NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Crofelemer suppliers with NDC on PharmaCompass.
Crofelemer 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 Crofelemer 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 Crofelemer GMP manufacturer or Crofelemer GMP API supplier for your needs.
A Crofelemer CoA (Certificate of Analysis) is a formal document that attests to Crofelemer's compliance with Crofelemer specifications and serves as a tool for batch-level quality control.
Crofelemer CoA mostly includes findings from lab analyses of a specific batch. For each Crofelemer 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.
Crofelemer may be tested according to a variety of international standards, such as European Pharmacopoeia (Crofelemer EP), Crofelemer JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Crofelemer USP).
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