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 1SODIUM DL-LACTATE SOLUTION 60%, USP (S-110, S110-M)
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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 : 7658
Submission : 1988-09-06
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 SODIUM DL-LACTATE SOLUTION 60%, USP (S-110, S110-M), with a corresponding US DMF Number 7658.
Remarkably, this DMF maintains an Active status since its submission on September 06, 1988, highlighting commitment to regulatory compliance.