01 1Farmhispania
01 1ATRACURIUM BESYLATE USP
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-01
Pay. Date : 2022-01-27
DMF Number : 11607
Submission : 1995-07-31
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 ATRACURIUM BESYLATE USP, with a corresponding US DMF Number 11607.
Remarkably, this DMF maintains an Active status since its submission on July 31, 1995, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 01, 2022, and payment made on January 27, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
