01 1Baxter Healthcare Corporation
01 1ICODEXTRIN POWDER
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14072
Submission : 1999-04-07
Status : Active
Type : II
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PharmaCompass offers a list of Icodextrin 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 Icodextrin manufacturer or Icodextrin supplier for your needs.
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A Icodextrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Icodextrin, including repackagers and relabelers. The FDA regulates Icodextrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Icodextrin 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 Icodextrin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Icodextrin supplier is an individual or a company that provides Icodextrin active pharmaceutical ingredient (API) or Icodextrin finished formulations upon request. The Icodextrin suppliers may include Icodextrin API manufacturers, exporters, distributors and traders.
click here to find a list of Icodextrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Icodextrin DMF (Drug Master File) is a document detailing the whole manufacturing process of Icodextrin active pharmaceutical ingredient (API) in detail. Different forms of Icodextrin DMFs exist exist since differing nations have different regulations, such as Icodextrin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Icodextrin DMF submitted to regulatory agencies in the US is known as a USDMF. Icodextrin USDMF includes data on Icodextrin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Icodextrin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Icodextrin suppliers with USDMF on PharmaCompass.
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