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ABOUT THIS PAGE
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PharmaCompass offers a list of Tezacaftor 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 Tezacaftor manufacturer or Tezacaftor supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tezacaftor manufacturer or Tezacaftor supplier.
PharmaCompass also assists you with knowing the Tezacaftor API Price utilized in the formulation of products. Tezacaftor API Price is not always fixed or binding as the Tezacaftor Price is obtained through a variety of data sources. The Tezacaftor Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tezacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tezacaftor, including repackagers and relabelers. The FDA regulates Tezacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tezacaftor 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 Tezacaftor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tezacaftor supplier is an individual or a company that provides Tezacaftor active pharmaceutical ingredient (API) or Tezacaftor finished formulations upon request. The Tezacaftor suppliers may include Tezacaftor API manufacturers, exporters, distributors and traders.
click here to find a list of Tezacaftor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tezacaftor DMF (Drug Master File) is a document detailing the whole manufacturing process of Tezacaftor active pharmaceutical ingredient (API) in detail. Different forms of Tezacaftor DMFs exist exist since differing nations have different regulations, such as Tezacaftor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tezacaftor DMF submitted to regulatory agencies in the US is known as a USDMF. Tezacaftor USDMF includes data on Tezacaftor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tezacaftor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tezacaftor suppliers with USDMF 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 Tezacaftor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tezacaftor 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 Tezacaftor 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 Tezacaftor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tezacaftor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tezacaftor suppliers with NDC on PharmaCompass.
Tezacaftor 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 Tezacaftor 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 Tezacaftor GMP manufacturer or Tezacaftor GMP API supplier for your needs.
A Tezacaftor CoA (Certificate of Analysis) is a formal document that attests to Tezacaftor's compliance with Tezacaftor specifications and serves as a tool for batch-level quality control.
Tezacaftor CoA mostly includes findings from lab analyses of a specific batch. For each Tezacaftor 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.
Tezacaftor may be tested according to a variety of international standards, such as European Pharmacopoeia (Tezacaftor EP), Tezacaftor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tezacaftor USP).
