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 1L-HISTIDINE HYDROCHLORIDE MONOHYDRATE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, BP, EP, JP, CHP (H-117)
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 : 39170
Submission : 2023-11-28
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 L-HISTIDINE HYDROCHLORIDE MONOHYDRATE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, BP, EP, JP, CHP (H-117), with a corresponding US DMF Number 39170.
Remarkably, this DMF maintains an Active status since its submission on November 28, 2023, highlighting commitment to regulatory compliance.
