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ABOUT THIS PAGE
A Tenapanor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tenapanor, including repackagers and relabelers. The FDA regulates Tenapanor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tenapanor 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 Tenapanor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tenapanor supplier is an individual or a company that provides Tenapanor active pharmaceutical ingredient (API) or Tenapanor finished formulations upon request. The Tenapanor suppliers may include Tenapanor API manufacturers, exporters, distributors and traders.
click here to find a list of Tenapanor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Tenapanor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tenapanor 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 Tenapanor 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 Tenapanor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tenapanor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tenapanor suppliers with NDC on PharmaCompass.
Tenapanor 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 Tenapanor 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 Tenapanor GMP manufacturer or Tenapanor GMP API supplier for your needs.
A Tenapanor CoA (Certificate of Analysis) is a formal document that attests to Tenapanor's compliance with Tenapanor specifications and serves as a tool for batch-level quality control.
Tenapanor CoA mostly includes findings from lab analyses of a specific batch. For each Tenapanor 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.
Tenapanor may be tested according to a variety of international standards, such as European Pharmacopoeia (Tenapanor EP), Tenapanor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tenapanor USP).
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