01 1Avesta Pharma
02 1Clariant
03 1Clariant Chemicals China Ltd
04 1JenKem Technology
05 2Nektar Therapeutics
06 1SIGMA TAU
07 3SUNBIO INC
08 1The Dow Chemical Company
09 3Xiamen SINOPEG Biotech
01 12-arm PEG-MAL(LYS01)-40K
02 14-ARM POLYETHYLENE GLYCOL AMINE 10,000
03 14-ARM POLYETHYLENE GLYCOL SUCCINIMIDYL GLUTARATE 10,000
04 18ARM PEG SUCCINIMIDYL GLUTARATE (HEXAGLYCEROL) MW 15000
05 1CARBOWAX POLYETHYLENE GLYCOL
06 1MACROGOLS (INN)=POLYETHYLENE GLYCOLS (NF)
07 1METHOXYPOLY (ETHYLENE GLYCOL) PROPIONALDEHYDE
08 1METHOXYPOLY (ETHYLENE GLYCOL) SUCCINIMIDYL SUCCINATE 5K
09 1METHOXYPOLY (ETHYLENE GLYCOL)- PROPIONALDEHYDE, MW 20, 000
10 1METHOXYPOLY (ETHYLENE GLYCOL)- SUCCINIMIDYL CARBONATE, MW 12,000
11 1POLYETHYLENE GLYCOL
12 1POLYETHYLENE GLYCOL 3350 USP
13 1POLYETHYLENE GLYCOL 3350 USP/NF
14 1POLYETHYLENE GLYCOL DISUCCINIMIDYL PROPIONATE 3,400
01 5China
02 1India
03 3South Korea
04 1Switzerland
05 4U.S.A
01 12Active
02 2Inactive
01 3Complete
02 11Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-05
Pay. Date : 2013-09-26
DMF Number : 27419
Submission : 2013-08-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13091
Submission : 1998-07-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-10
Pay. Date : 2018-02-28
DMF Number : 32355
Submission : 2018-03-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30302
Submission : 2015-10-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27131
Submission : 2000-06-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30155
Submission : 2015-12-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29395
Submission : 2015-05-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30610
Submission : 2016-05-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-11-16
DMF Number : 1356
Submission : 1969-03-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31041
Submission : 2016-09-25
Status : Active
Type : II
A Macrogol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Macrogol, including repackagers and relabelers. The FDA regulates Macrogol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Macrogol 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 Macrogol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Macrogol supplier is an individual or a company that provides Macrogol active pharmaceutical ingredient (API) or Macrogol finished formulations upon request. The Macrogol suppliers may include Macrogol API manufacturers, exporters, distributors and traders.
click here to find a list of Macrogol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Macrogol DMF (Drug Master File) is a document detailing the whole manufacturing process of Macrogol active pharmaceutical ingredient (API) in detail. Different forms of Macrogol DMFs exist exist since differing nations have different regulations, such as Macrogol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Macrogol DMF submitted to regulatory agencies in the US is known as a USDMF. Macrogol USDMF includes data on Macrogol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Macrogol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Macrogol suppliers with USDMF on PharmaCompass.
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