01 1Farmhispania
01 1ROCURONIUM BROMIDE USP-PROCESS II
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-10-03
Pay. Date : 2025-07-18
DMF Number : 41894
Submission : 2025-05-29
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 ROCURONIUM BROMIDE USP-PROCESS II, with a corresponding US DMF Number 41894.
Remarkably, this DMF maintains an Active status since its submission on May 29, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 03, 2025, and payment made on July 18, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
