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