01 1SIGMA TAU
01 1STEARYLAMINE AS PROCESSED BY ARMAK FOR SIGMA F & D
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5264
Submission : 1983-07-27
Status : Inactive
Type : II
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A octadecylamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of octadecylamine, including repackagers and relabelers. The FDA regulates octadecylamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. octadecylamine 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 octadecylamine supplier is an individual or a company that provides octadecylamine active pharmaceutical ingredient (API) or octadecylamine finished formulations upon request. The octadecylamine suppliers may include octadecylamine API manufacturers, exporters, distributors and traders.
click here to find a list of octadecylamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A octadecylamine DMF (Drug Master File) is a document detailing the whole manufacturing process of octadecylamine active pharmaceutical ingredient (API) in detail. Different forms of octadecylamine DMFs exist exist since differing nations have different regulations, such as octadecylamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A octadecylamine DMF submitted to regulatory agencies in the US is known as a USDMF. octadecylamine USDMF includes data on octadecylamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The octadecylamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of octadecylamine suppliers with USDMF on PharmaCompass.
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