01 1CSL Vifor
01 1CARBOXYMETHYLATED DEXTRAN (CM DEXTRAN)
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25256
Submission : 2011-09-01
Status : Inactive
Type : II
15
PharmaCompass offers a list of Carboxymethylated Dextran 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 Carboxymethylated Dextran manufacturer or Carboxymethylated Dextran supplier for your needs.
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A Carboxymethylated Dextran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carboxymethylated Dextran, including repackagers and relabelers. The FDA regulates Carboxymethylated Dextran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carboxymethylated Dextran 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 Carboxymethylated Dextran supplier is an individual or a company that provides Carboxymethylated Dextran active pharmaceutical ingredient (API) or Carboxymethylated Dextran finished formulations upon request. The Carboxymethylated Dextran suppliers may include Carboxymethylated Dextran API manufacturers, exporters, distributors and traders.
click here to find a list of Carboxymethylated Dextran suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Carboxymethylated Dextran DMF (Drug Master File) is a document detailing the whole manufacturing process of Carboxymethylated Dextran active pharmaceutical ingredient (API) in detail. Different forms of Carboxymethylated Dextran DMFs exist exist since differing nations have different regulations, such as Carboxymethylated Dextran USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carboxymethylated Dextran DMF submitted to regulatory agencies in the US is known as a USDMF. Carboxymethylated Dextran USDMF includes data on Carboxymethylated Dextran's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carboxymethylated Dextran USDMF is kept confidential to protect the manufacturer’s intellectual property.
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