01 1SAFC
01 1ETHYLENE OXIDE STERILISATION
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17262
Submission : 2004-03-26
Status : Inactive
Type : II
A Tramiprosate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tramiprosate, including repackagers and relabelers. The FDA regulates Tramiprosate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tramiprosate 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 Tramiprosate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tramiprosate supplier is an individual or a company that provides Tramiprosate active pharmaceutical ingredient (API) or Tramiprosate finished formulations upon request. The Tramiprosate suppliers may include Tramiprosate API manufacturers, exporters, distributors and traders.
click here to find a list of Tramiprosate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tramiprosate DMF (Drug Master File) is a document detailing the whole manufacturing process of Tramiprosate active pharmaceutical ingredient (API) in detail. Different forms of Tramiprosate DMFs exist exist since differing nations have different regulations, such as Tramiprosate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tramiprosate DMF submitted to regulatory agencies in the US is known as a USDMF. Tramiprosate USDMF includes data on Tramiprosate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tramiprosate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tramiprosate suppliers with USDMF on PharmaCompass.
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