01 2Avanti Polar Lipids
01 1TRICAPRYLIN (730412)
02 1TRIOCTANOIN
01 2U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31820
Submission : 2017-08-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12185
Submission : 1996-10-22
Status : Active
Type : II
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A Axona manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Axona, including repackagers and relabelers. The FDA regulates Axona manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Axona API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Axona supplier is an individual or a company that provides Axona active pharmaceutical ingredient (API) or Axona finished formulations upon request. The Axona suppliers may include Axona API manufacturers, exporters, distributors and traders.
click here to find a list of Axona suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Axona DMF (Drug Master File) is a document detailing the whole manufacturing process of Axona active pharmaceutical ingredient (API) in detail. Different forms of Axona DMFs exist exist since differing nations have different regulations, such as Axona USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Axona DMF submitted to regulatory agencies in the US is known as a USDMF. Axona USDMF includes data on Axona's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Axona USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Axona suppliers with USDMF on PharmaCompass.
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