01 1Kyowa Hakko Bio
01 1AICA-RIBOSIDE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8405
Submission : 1990-01-25
Status : Inactive
Type : II
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PharmaCompass offers a list of Acadesine 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 Acadesine manufacturer or Acadesine supplier for your needs.
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A Acadesine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acadesine, including repackagers and relabelers. The FDA regulates Acadesine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acadesine 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 Acadesine supplier is an individual or a company that provides Acadesine active pharmaceutical ingredient (API) or Acadesine finished formulations upon request. The Acadesine suppliers may include Acadesine API manufacturers, exporters, distributors and traders.
click here to find a list of Acadesine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Acadesine DMF (Drug Master File) is a document detailing the whole manufacturing process of Acadesine active pharmaceutical ingredient (API) in detail. Different forms of Acadesine DMFs exist exist since differing nations have different regulations, such as Acadesine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acadesine DMF submitted to regulatory agencies in the US is known as a USDMF. Acadesine USDMF includes data on Acadesine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acadesine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acadesine suppliers with USDMF on PharmaCompass.
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