01 1Cargill SLU
02 1Roquette
03 1Weifang Shengtai Pharmaceutical
01 1C* PHARMDEX 02010 (GLUCOSE MONOHYDRATE)
02 1DEXTROSE MONOHYDRATE
03 1DEXTROSE MONOHYDRATE USP GRADE (LYCADEX® PF)
01 1China
02 1France
03 1Spain
01 3Active
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31910
Submission : 2017-11-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-01
Pay. Date : 2014-04-29
DMF Number : 4697
Submission : 1982-10-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30079
Submission : 2015-11-23
Status : Active
Type : II
A Dextrose Monohydrate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextrose Monohydrate API, including repackagers and relabelers. The FDA regulates Dextrose Monohydrate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextrose Monohydrate API 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 Dextrose Monohydrate API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dextrose Monohydrate API supplier is an individual or a company that provides Dextrose Monohydrate API active pharmaceutical ingredient (API) or Dextrose Monohydrate API finished formulations upon request. The Dextrose Monohydrate API suppliers may include Dextrose Monohydrate API API manufacturers, exporters, distributors and traders.
click here to find a list of Dextrose Monohydrate API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dextrose Monohydrate API DMF (Drug Master File) is a document detailing the whole manufacturing process of Dextrose Monohydrate API active pharmaceutical ingredient (API) in detail. Different forms of Dextrose Monohydrate API DMFs exist exist since differing nations have different regulations, such as Dextrose Monohydrate API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dextrose Monohydrate API DMF submitted to regulatory agencies in the US is known as a USDMF. Dextrose Monohydrate API USDMF includes data on Dextrose Monohydrate API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dextrose Monohydrate API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dextrose Monohydrate API suppliers with USDMF on PharmaCompass.
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