01 1Rhodia Organique SAS
01 1ETHOPROPAZINE
01 1France
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 536
Submission : 1963-04-12
Status : Inactive
Type : II
A Profenamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Profenamine, including repackagers and relabelers. The FDA regulates Profenamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Profenamine 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 Profenamine supplier is an individual or a company that provides Profenamine active pharmaceutical ingredient (API) or Profenamine finished formulations upon request. The Profenamine suppliers may include Profenamine API manufacturers, exporters, distributors and traders.
click here to find a list of Profenamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Profenamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Profenamine active pharmaceutical ingredient (API) in detail. Different forms of Profenamine DMFs exist exist since differing nations have different regulations, such as Profenamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Profenamine DMF submitted to regulatory agencies in the US is known as a USDMF. Profenamine USDMF includes data on Profenamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Profenamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Profenamine suppliers with USDMF on PharmaCompass.
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