Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
KEY PRODUCTS
KEY EXCIPIENTS
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01 1Pfanstiehl
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01 1D-MANNOSE, HIGH PURITY, LOW ENDOTOXIN LOW METALS (M-164-2)
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01 1U.S.A
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01 1Active
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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 : 40291
Submission : 2024-07-31
Status : Active
Type : II
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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-MANNOSE, HIGH PURITY, LOW ENDOTOXIN LOW METALS (M-164-2), with a corresponding US DMF Number 40291.
Remarkably, this DMF maintains an Active status since its submission on July 31, 2024, highlighting commitment to regulatory compliance.