01 1Procos
01 1PROGLUMIDE
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3745
Submission : 1980-03-07
Status : Inactive
Type : II
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PharmaCompass offers a list of Proglumide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Proglumide manufacturer or Proglumide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Proglumide manufacturer or Proglumide supplier.
A Proglumide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Proglumide, including repackagers and relabelers. The FDA regulates Proglumide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Proglumide 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 Proglumide supplier is an individual or a company that provides Proglumide active pharmaceutical ingredient (API) or Proglumide finished formulations upon request. The Proglumide suppliers may include Proglumide API manufacturers, exporters, distributors and traders.
click here to find a list of Proglumide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Proglumide DMF (Drug Master File) is a document detailing the whole manufacturing process of Proglumide active pharmaceutical ingredient (API) in detail. Different forms of Proglumide DMFs exist exist since differing nations have different regulations, such as Proglumide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Proglumide DMF submitted to regulatory agencies in the US is known as a USDMF. Proglumide USDMF includes data on Proglumide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Proglumide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Proglumide suppliers with USDMF on PharmaCompass.
