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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A THAM-E manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of THAM-E, including repackagers and relabelers. The FDA regulates THAM-E manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. THAM-E 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 THAM-E DMF (Drug Master File) is a document detailing the whole manufacturing process of THAM-E active pharmaceutical ingredient (API) in detail. Different forms of THAM-E DMFs exist exist since differing nations have different regulations, such as THAM-E USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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