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