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01 1Angelini Pharma
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01 1LONIDAMINE
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01 1Italy
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01 1Inactive
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01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4314
Submission : 1981-11-09
Status : Inactive
Type : II
A Lonidamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lonidamine, including repackagers and relabelers. The FDA regulates Lonidamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lonidamine 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 Lonidamine supplier is an individual or a company that provides Lonidamine active pharmaceutical ingredient (API) or Lonidamine finished formulations upon request. The Lonidamine suppliers may include Lonidamine API manufacturers, exporters, distributors and traders.
click here to find a list of Lonidamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lonidamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Lonidamine active pharmaceutical ingredient (API) in detail. Different forms of Lonidamine DMFs exist exist since differing nations have different regulations, such as Lonidamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lonidamine DMF submitted to regulatory agencies in the US is known as a USDMF. Lonidamine USDMF includes data on Lonidamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lonidamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lonidamine suppliers with USDMF on PharmaCompass.
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