01 1Avanti Polar Lipids
02 1Hubei Gedian Humanwell Pharmaceutical
03 1SIGMA TAU
01 1MEDIUM-CHAIN TRIGLYCERIDES
02 2TRIOLEIN
01 1China
02 2U.S.A
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12104
Submission : 1996-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36921
Submission : 2022-07-04
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8424
Submission : 1990-01-01
Status : Inactive
Type : II
A Triolein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Triolein, including repackagers and relabelers. The FDA regulates Triolein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Triolein 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 Triolein manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Triolein supplier is an individual or a company that provides Triolein active pharmaceutical ingredient (API) or Triolein finished formulations upon request. The Triolein suppliers may include Triolein API manufacturers, exporters, distributors and traders.
click here to find a list of Triolein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Triolein DMF (Drug Master File) is a document detailing the whole manufacturing process of Triolein active pharmaceutical ingredient (API) in detail. Different forms of Triolein DMFs exist exist since differing nations have different regulations, such as Triolein USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Triolein DMF submitted to regulatory agencies in the US is known as a USDMF. Triolein USDMF includes data on Triolein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Triolein USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Triolein suppliers with USDMF on PharmaCompass.
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