01 1PolyPeptide Group
01 1HIRULOG (BIVALIRUDIN)- ACTIVE PHARMACEUTICAL INGREDIENT
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12797
Submission : 1997-12-22
Status : Inactive
Type : II
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Polypeptide Sa, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is HIRULOG (BIVALIRUDIN)- ACTIVE PHARMACEUTICAL INGREDIENT, with a corresponding US DMF Number 12797.
Remarkably, this DMF maintains an Inactive status since its submission on December 22, 1997, highlighting commitment to regulatory compliance.
