01 1Henkel AG & Co. KGaA
01 1FATTY ACIDS
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1011
Submission : 1966-11-21
Status : Inactive
Type : II
95
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A Amasil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amasil, including repackagers and relabelers. The FDA regulates Amasil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amasil 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 Amasil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Amasil supplier is an individual or a company that provides Amasil active pharmaceutical ingredient (API) or Amasil finished formulations upon request. The Amasil suppliers may include Amasil API manufacturers, exporters, distributors and traders.
click here to find a list of Amasil suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Amasil DMF (Drug Master File) is a document detailing the whole manufacturing process of Amasil active pharmaceutical ingredient (API) in detail. Different forms of Amasil DMFs exist exist since differing nations have different regulations, such as Amasil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amasil DMF submitted to regulatory agencies in the US is known as a USDMF. Amasil USDMF includes data on Amasil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amasil USDMF is kept confidential to protect the manufacturer’s intellectual property.
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