01 1Catalent Pharma Solutions
01 1ATRASENTAN HYDROCHLORIDE, SOFT GELATIN CAPSULES, 10 MG (BASE EQUIVALENT)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17686
Submission : 2004-09-05
Status : Inactive
Type : II
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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.
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