Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1ANGUS Chemical Company
03 1Abbott Laboratories
04 1BioSpectra
05 1F. Hoffmann-La Roche
06 1SIGMA TAU
07 1Takara Bio
08 1The Mosaic Company
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42613
Submission : 2025-09-22
Status :
Type : II
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PharmaCompass offers a list of Tromethamine API API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Tromethamine API manufacturer or Tromethamine API supplier for your needs.
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A TROMETAMOL API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TROMETAMOL API, including repackagers and relabelers. The FDA regulates TROMETAMOL API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TROMETAMOL API API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A TROMETAMOL API supplier is an individual or a company that provides TROMETAMOL API active pharmaceutical ingredient (API) or TROMETAMOL API finished formulations upon request. The TROMETAMOL API suppliers may include TROMETAMOL API API manufacturers, exporters, distributors and traders.
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A TROMETAMOL API DMF (Drug Master File) is a document detailing the whole manufacturing process of TROMETAMOL API active pharmaceutical ingredient (API) in detail. Different forms of TROMETAMOL API DMFs exist exist since differing nations have different regulations, such as TROMETAMOL API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TROMETAMOL API DMF submitted to regulatory agencies in the US is known as a USDMF. TROMETAMOL API USDMF includes data on TROMETAMOL API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TROMETAMOL API USDMF is kept confidential to protect the manufacturer’s intellectual property.
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