01 1Curia
01 1ARGATROBAN MONOHYDRATE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-15
Pay. Date : 2024-09-10
DMF Number : 40227
Submission : 2024-08-30
Status : Active
Type : II
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Curia Italy Srl, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
One of their notable products is ARGATROBAN MONOHYDRATE, with a corresponding US DMF Number 40227.
Remarkably, this DMF maintains an Active status since its submission on August 30, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 15, 2024, and payment made on September 10, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
