01 1Farmhispania
01 1DECITABINE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-01-30
Pay. Date : 2025-01-21
DMF Number : 34163
Submission : 2019-10-08
Status : Active
Type : II
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Farmhispania Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
One of their notable products is DECITABINE, with a corresponding US DMF Number 34163.
Remarkably, this DMF maintains an Active status since its submission on October 08, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 30, 2025, and payment made on January 21, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
