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NDC API
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USP
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FDF Dossiers
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FDA Orange Book
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Europe
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Atrasentan
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Chinook Therapeutics
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Chinook Therapeutics in-license of atrasentan provides a unique opportunity for Chinook to add a potential new drug to its precision medicine portfolio for the treatment of rare CKD conditions.
Product Name : CHK-01
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 01, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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ABOUT THIS PAGE
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PharmaCompass offers a list of Atrasentan 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 Atrasentan manufacturer or Atrasentan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Atrasentan manufacturer or Atrasentan supplier.
PharmaCompass also assists you with knowing the Atrasentan API Price utilized in the formulation of products. Atrasentan API Price is not always fixed or binding as the Atrasentan Price is obtained through a variety of data sources. The Atrasentan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Atrasentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atrasentan, including repackagers and relabelers. The FDA regulates Atrasentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atrasentan 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 Atrasentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Atrasentan supplier is an individual or a company that provides Atrasentan active pharmaceutical ingredient (API) or Atrasentan finished formulations upon request. The Atrasentan suppliers may include Atrasentan API manufacturers, exporters, distributors and traders.
click here to find a list of Atrasentan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Atrasentan DMF (Drug Master File) is a document detailing the whole manufacturing process of Atrasentan active pharmaceutical ingredient (API) in detail. Different forms of Atrasentan DMFs exist exist since differing nations have different regulations, such as Atrasentan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atrasentan DMF submitted to regulatory agencies in the US is known as a USDMF. Atrasentan USDMF includes data on Atrasentan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atrasentan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atrasentan suppliers with USDMF on PharmaCompass.
Atrasentan 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 Atrasentan 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 Atrasentan GMP manufacturer or Atrasentan GMP API supplier for your needs.
A Atrasentan CoA (Certificate of Analysis) is a formal document that attests to Atrasentan's compliance with Atrasentan specifications and serves as a tool for batch-level quality control.
Atrasentan CoA mostly includes findings from lab analyses of a specific batch. For each Atrasentan 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.
Atrasentan may be tested according to a variety of international standards, such as European Pharmacopoeia (Atrasentan EP), Atrasentan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atrasentan USP).
