01 1Hikma Pharmaceuticals
01 1HIK-079
01 1United Kingdom
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-30
Pay. Date : 2021-10-04
DMF Number : 33746
Submission : 2019-04-01
Status : Active
Type : II
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Hikma Pharmaceuticals Llc, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is HIK-079, with a corresponding US DMF Number 33746.
Remarkably, this DMF maintains an Active status since its submission on April 01, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 30, 2021, and payment made on October 04, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
