01 1Farmhispania
01 1SUGAMMADEX SODIUM
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-04
Pay. Date : 2020-10-28
DMF Number : 35319
Submission : 2020-10-29
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 SUGAMMADEX SODIUM, with a corresponding US DMF Number 35319.
Remarkably, this DMF maintains an Active status since its submission on October 29, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 04, 2021, and payment made on October 28, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
