01 2Avanti Polar Lipids
02 1Lonza Group
03 1STEPAN SPECIALTY PRODUCTS LLC
01 11,2-DIMYRISTOYL-SN-GLYCERO-3[PHOSPHO-RAC-(1-GLYCEROL)]
02 11,2-DIPALMITOYL-SN-GLYCERO-3-[PHOSPHO-RAC-(1-GLYCEROL)] (SODIUM SALT) (770255)
03 1GLYCEROL MONOCAPRYLOCAPRATE
04 1POLYGLYCEROL-6
01 1Switzerland
02 3U.S.A
01 4Active
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9284
Submission : 1991-08-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16080
Submission : 2002-08-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26941
Submission : 2013-02-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32997
Submission : 2018-10-26
Status : Active
Type : IV
A Glycerine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycerine, including repackagers and relabelers. The FDA regulates Glycerine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycerine 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 Glycerine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycerine supplier is an individual or a company that provides Glycerine active pharmaceutical ingredient (API) or Glycerine finished formulations upon request. The Glycerine suppliers may include Glycerine API manufacturers, exporters, distributors and traders.
click here to find a list of Glycerine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycerine DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycerine active pharmaceutical ingredient (API) in detail. Different forms of Glycerine DMFs exist exist since differing nations have different regulations, such as Glycerine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycerine DMF submitted to regulatory agencies in the US is known as a USDMF. Glycerine USDMF includes data on Glycerine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycerine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycerine suppliers with USDMF on PharmaCompass.
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