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 : 16080
Submission : 2002-08-01
Status : Active
Type : II
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 : 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 1,2,3-Propanetriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,2,3-Propanetriol, including repackagers and relabelers. The FDA regulates 1,2,3-Propanetriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,2,3-Propanetriol 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 1,2,3-Propanetriol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1,2,3-Propanetriol supplier is an individual or a company that provides 1,2,3-Propanetriol active pharmaceutical ingredient (API) or 1,2,3-Propanetriol finished formulations upon request. The 1,2,3-Propanetriol suppliers may include 1,2,3-Propanetriol API manufacturers, exporters, distributors and traders.
click here to find a list of 1,2,3-Propanetriol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1,2,3-Propanetriol DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,2,3-Propanetriol active pharmaceutical ingredient (API) in detail. Different forms of 1,2,3-Propanetriol DMFs exist exist since differing nations have different regulations, such as 1,2,3-Propanetriol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1,2,3-Propanetriol DMF submitted to regulatory agencies in the US is known as a USDMF. 1,2,3-Propanetriol USDMF includes data on 1,2,3-Propanetriol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,2,3-Propanetriol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1,2,3-Propanetriol suppliers with USDMF on PharmaCompass.
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