01 1SAFC
01 11-HEXADECANOL
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9969
Submission : 1992-11-13
Status : Inactive
Type : II
A Cetyl Alcohol API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetyl Alcohol API, including repackagers and relabelers. The FDA regulates Cetyl Alcohol API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetyl Alcohol API 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 Cetyl Alcohol API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetyl Alcohol API supplier is an individual or a company that provides Cetyl Alcohol API active pharmaceutical ingredient (API) or Cetyl Alcohol API finished formulations upon request. The Cetyl Alcohol API suppliers may include Cetyl Alcohol API API manufacturers, exporters, distributors and traders.
click here to find a list of Cetyl Alcohol API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cetyl Alcohol API DMF (Drug Master File) is a document detailing the whole manufacturing process of Cetyl Alcohol API active pharmaceutical ingredient (API) in detail. Different forms of Cetyl Alcohol API DMFs exist exist since differing nations have different regulations, such as Cetyl Alcohol API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cetyl Alcohol API DMF submitted to regulatory agencies in the US is known as a USDMF. Cetyl Alcohol API USDMF includes data on Cetyl Alcohol API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetyl Alcohol API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cetyl Alcohol API suppliers with USDMF on PharmaCompass.
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