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01 1RO 12-1989 (DIHOMO-GRAMMA-LINOLENIC ACID)
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4123
Submission : 1981-04-14
Status : Inactive
Type : II
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A Dihomo-Gamma-Linolenate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dihomo-Gamma-Linolenate, including repackagers and relabelers. The FDA regulates Dihomo-Gamma-Linolenate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dihomo-Gamma-Linolenate 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 Dihomo-Gamma-Linolenate supplier is an individual or a company that provides Dihomo-Gamma-Linolenate active pharmaceutical ingredient (API) or Dihomo-Gamma-Linolenate finished formulations upon request. The Dihomo-Gamma-Linolenate suppliers may include Dihomo-Gamma-Linolenate API manufacturers, exporters, distributors and traders.
click here to find a list of Dihomo-Gamma-Linolenate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dihomo-Gamma-Linolenate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dihomo-Gamma-Linolenate active pharmaceutical ingredient (API) in detail. Different forms of Dihomo-Gamma-Linolenate DMFs exist exist since differing nations have different regulations, such as Dihomo-Gamma-Linolenate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dihomo-Gamma-Linolenate DMF submitted to regulatory agencies in the US is known as a USDMF. Dihomo-Gamma-Linolenate USDMF includes data on Dihomo-Gamma-Linolenate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dihomo-Gamma-Linolenate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dihomo-Gamma-Linolenate suppliers with USDMF on PharmaCompass.
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