01 1Hikma Pharmaceuticals
01 1HIK-078
01 1United Kingdom
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-17
Pay. Date : 2021-07-28
DMF Number : 33269
Submission : 2019-10-31
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-078, with a corresponding US DMF Number 33269.
Remarkably, this DMF maintains an Active status since its submission on October 31, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 17, 2021, and payment made on July 28, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
