01 2Actylis
02 2Kyowa Hakko Bio
03 2SIGMA TAU
01 1GLUTATHIONE OXIDIZED
02 1GLUTATHIONE REDUCED (GSH)
03 1GLUTATHIONE, FREE ACID REDUCED FORM
04 1GLUTATHIONE, OXIDIZED HYDRATE
05 1MANUFACTURING AND QUALITY INFORMATION ON L-GLUTATHIONE REDUCED
06 1MANUFACTURING AND QUALITY INFORMATION ON L-GLUTATHIONE OXIDIZED
01 2Japan
02 4U.S.A
01 1Active
02 5Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3068
Submission : 1977-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2562
Submission : 1975-11-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7799
Submission : 1988-12-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8893
Submission : 1990-12-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4278
Submission : 1981-09-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3043
Submission : 1977-10-21
Status : Inactive
Type : II
A Glutathione manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glutathione, including repackagers and relabelers. The FDA regulates Glutathione manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glutathione 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 Glutathione manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glutathione supplier is an individual or a company that provides Glutathione active pharmaceutical ingredient (API) or Glutathione finished formulations upon request. The Glutathione suppliers may include Glutathione API manufacturers, exporters, distributors and traders.
click here to find a list of Glutathione suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glutathione DMF (Drug Master File) is a document detailing the whole manufacturing process of Glutathione active pharmaceutical ingredient (API) in detail. Different forms of Glutathione DMFs exist exist since differing nations have different regulations, such as Glutathione USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glutathione DMF submitted to regulatory agencies in the US is known as a USDMF. Glutathione USDMF includes data on Glutathione's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glutathione USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glutathione suppliers with USDMF on PharmaCompass.
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