01 1Roche Diagnostics GmbH
02 1SIGMA TAU
03 1Shanghai Hegeng Industrial Co. Ltd
01 1D (+) GALACTOSE PRODUCT NO. G 0750 FD
02 1D-GALACTOSE
03 1GALACTOSE, THERAPEUTIC GRADE
01 1China
02 1Germany
03 1U.S.A
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8650
Submission : 1990-07-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33700
Submission : 2019-03-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7786
Submission : 1988-11-18
Status : Inactive
Type : II
A Alpha-D-Galactose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpha-D-Galactose, including repackagers and relabelers. The FDA regulates Alpha-D-Galactose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpha-D-Galactose 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 Alpha-D-Galactose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alpha-D-Galactose supplier is an individual or a company that provides Alpha-D-Galactose active pharmaceutical ingredient (API) or Alpha-D-Galactose finished formulations upon request. The Alpha-D-Galactose suppliers may include Alpha-D-Galactose API manufacturers, exporters, distributors and traders.
click here to find a list of Alpha-D-Galactose suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alpha-D-Galactose DMF (Drug Master File) is a document detailing the whole manufacturing process of Alpha-D-Galactose active pharmaceutical ingredient (API) in detail. Different forms of Alpha-D-Galactose DMFs exist exist since differing nations have different regulations, such as Alpha-D-Galactose USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alpha-D-Galactose DMF submitted to regulatory agencies in the US is known as a USDMF. Alpha-D-Galactose USDMF includes data on Alpha-D-Galactose's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alpha-D-Galactose USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alpha-D-Galactose suppliers with USDMF on PharmaCompass.
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