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 1SODIUM GLUCONATE, USP (S-108)
01 1U.S.A
01 1Active
01 1Complete
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-14
Pay. Date : 2021-09-09
DMF Number : 9147
Submission : 1991-05-31
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 SODIUM GLUCONATE, USP (S-108), with a corresponding US DMF Number 9147.
Remarkably, this DMF maintains an Active status since its submission on May 31, 1991, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 14, 2021, and payment made on September 09, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
