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