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-GALACTOSE, PLANT DERIVED HIGH PURITY LOW ENDOTOXIN / LOW METAL, NF, EP (G-126-3)
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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 : 38846
Submission : 2023-09-20
Status : Active
Type : IV
20
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-GALACTOSE, PLANT DERIVED HIGH PURITY LOW ENDOTOXIN / LOW METAL, NF, EP (G-126-3), with a corresponding US DMF Number 38846.
Remarkably, this DMF maintains an Active status since its submission on September 20, 2023, highlighting commitment to regulatory compliance.