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01 1ELTENAC/B 7808-020 DRUG SUBSTANCE
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11016
Submission : 1994-08-01
Status : Inactive
Type : II
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PharmaCompass offers a list of Eltenac API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Eltenac manufacturer or Eltenac supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eltenac manufacturer or Eltenac supplier.
A Eltenac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eltenac, including repackagers and relabelers. The FDA regulates Eltenac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eltenac 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 Eltenac supplier is an individual or a company that provides Eltenac active pharmaceutical ingredient (API) or Eltenac finished formulations upon request. The Eltenac suppliers may include Eltenac API manufacturers, exporters, distributors and traders.
click here to find a list of Eltenac suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Eltenac DMF (Drug Master File) is a document detailing the whole manufacturing process of Eltenac active pharmaceutical ingredient (API) in detail. Different forms of Eltenac DMFs exist exist since differing nations have different regulations, such as Eltenac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eltenac DMF submitted to regulatory agencies in the US is known as a USDMF. Eltenac USDMF includes data on Eltenac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eltenac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eltenac suppliers with USDMF on PharmaCompass.
