01 1Actavis Inc
01 1ALVIMOPAN DIHYDRATE
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-19
Pay. Date : 2016-05-18
DMF Number : 30553
Submission : 2016-05-24
Status : Active
Type : II
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Tapi Nl Bv, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ALVIMOPAN DIHYDRATE, with a corresponding US DMF Number 30553.
Remarkably, this DMF maintains an Active status since its submission on May 24, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 19, 2016, and payment made on May 18, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
