01 1Novartis Pharmaceuticals Corporation
01 1PYRILAMINE BASE
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6601
Submission : 1986-09-24
Status : Inactive
Type : II
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A Antamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Antamine, including repackagers and relabelers. The FDA regulates Antamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Antamine 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 Antamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Antamine supplier is an individual or a company that provides Antamine active pharmaceutical ingredient (API) or Antamine finished formulations upon request. The Antamine suppliers may include Antamine API manufacturers, exporters, distributors and traders.
click here to find a list of Antamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Antamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Antamine active pharmaceutical ingredient (API) in detail. Different forms of Antamine DMFs exist exist since differing nations have different regulations, such as Antamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Antamine DMF submitted to regulatory agencies in the US is known as a USDMF. Antamine USDMF includes data on Antamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Antamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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