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