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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PharmaCompass offers a list of Stearylamine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Stearylamine manufacturer or Stearylamine supplier for your needs.
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A Stearylamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stearylamine, including repackagers and relabelers. The FDA regulates Stearylamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stearylamine 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 Stearylamine supplier is an individual or a company that provides Stearylamine active pharmaceutical ingredient (API) or Stearylamine finished formulations upon request. The Stearylamine suppliers may include Stearylamine API manufacturers, exporters, distributors and traders.
click here to find a list of Stearylamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Stearylamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Stearylamine active pharmaceutical ingredient (API) in detail. Different forms of Stearylamine DMFs exist exist since differing nations have different regulations, such as Stearylamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Stearylamine DMF submitted to regulatory agencies in the US is known as a USDMF. Stearylamine USDMF includes data on Stearylamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Stearylamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Stearylamine suppliers with USDMF on PharmaCompass.
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