01 1SAFC
01 1GALACTOMANNAN C (DAVANAT)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21629
Submission : 2008-05-16
Status : Inactive
Type : II
A Galactomannan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Galactomannan, including repackagers and relabelers. The FDA regulates Galactomannan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Galactomannan 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 Galactomannan supplier is an individual or a company that provides Galactomannan active pharmaceutical ingredient (API) or Galactomannan finished formulations upon request. The Galactomannan suppliers may include Galactomannan API manufacturers, exporters, distributors and traders.
click here to find a list of Galactomannan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Galactomannan DMF (Drug Master File) is a document detailing the whole manufacturing process of Galactomannan active pharmaceutical ingredient (API) in detail. Different forms of Galactomannan DMFs exist exist since differing nations have different regulations, such as Galactomannan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Galactomannan DMF submitted to regulatory agencies in the US is known as a USDMF. Galactomannan USDMF includes data on Galactomannan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Galactomannan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Galactomannan suppliers with USDMF on PharmaCompass.
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