01 1SAFC
01 1U.S.A
01 1Inactive
01 1Blank
01 1Blank
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.
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