01 4JenKem Technology
02 1SUNBIO
03 3SUNBIO INC
04 1The Dow Chemical Company
01 1CARBOWAX SENTRY METHOXYPOLYETHYLENE GLYCOL
02 1METHOXY PEG DIMYRISTOYL-RAC-GLYCERO, MW 2000 (M-DMG-2000)
03 1METHOXY PEG DITETRADECYLACETAMIDE (MW 2000), OR M-DTDAM-2000 (ALC-0159)
04 1METHOXY PEG PROPIONALDEHYDE MW 20000
05 1METHOXY PEG SUCCINIMIDYL SUCCINATE MW20000
06 1METHOXY POLYETHYLENE GLYCOL AMINE 2,000
07 1METHOXY POLYETHYLENE GLYCOL BENZOTRIAZOLYL CARBONATE 20,000
08 1METHOXY POLYETHYLENE GLYCOL DISUCCINIMIDYL PROPIONATE 3,400
09 1METHOXY POLYETHYLENE GLYCOL PROPIONALDEHYDE 20,000
01 4China
02 4South Korea
03 1U.S.A
01 7Active
02 2Inactive
01 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38522
Submission : 2023-07-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37950
Submission : 2023-01-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36306
Submission : 2021-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30145
Submission : 2015-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25501
Submission : 2011-11-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29343
Submission : 2015-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25835
Submission : 2012-02-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27352
Submission : 2013-07-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9385
Submission : 1991-10-24
Status : Inactive
Type : IV
57
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A Tox21_301080 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tox21_301080, including repackagers and relabelers. The FDA regulates Tox21_301080 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tox21_301080 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Tox21_301080 DMF (Drug Master File) is a document detailing the whole manufacturing process of Tox21_301080 active pharmaceutical ingredient (API) in detail. Different forms of Tox21_301080 DMFs exist exist since differing nations have different regulations, such as Tox21_301080 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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