KEY PRODUCTS
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
01 1D-MANNITOL (PLANT DERIVED) HIGH PURITY / LOW ENDOTOXIN-LOW METALS USP/EP/JP/CHP (M-109-7)
01 1U.S.A
01 1Active
01 1Blank
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 : 32464
Submission : 2018-02-15
Status : Active
Type : IV
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Pfanstiehl Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
One of their notable products is D-MANNITOL (PLANT DERIVED) HIGH PURITY / LOW ENDOTOXIN-LOW METALS USP/EP/JP/CHP (M-109-7), with a corresponding US DMF Number 32464.
Remarkably, this DMF maintains an Active status since its submission on February 15, 2018, highlighting commitment to regulatory compliance.
