01 1Waitaki Biosciences
02 1Blank
01 2LINOLEIC ACID
01 1New Zealand
02 1Blank
01 2Inactive
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6706
Submission : 1986-12-04
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9288
Submission : 1991-08-13
Status : Inactive
Type : II
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A Linoleic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Linoleic Acid, including repackagers and relabelers. The FDA regulates Linoleic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Linoleic Acid 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 Linoleic Acid supplier is an individual or a company that provides Linoleic Acid active pharmaceutical ingredient (API) or Linoleic Acid finished formulations upon request. The Linoleic Acid suppliers may include Linoleic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Linoleic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Linoleic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Linoleic Acid active pharmaceutical ingredient (API) in detail. Different forms of Linoleic Acid DMFs exist exist since differing nations have different regulations, such as Linoleic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Linoleic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Linoleic Acid USDMF includes data on Linoleic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Linoleic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Linoleic Acid suppliers with USDMF on PharmaCompass.
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