01 1TopChem Pharmaceuticals
01 1TOLCAPONE
01 1Ireland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-15
Pay. Date : 2014-06-11
DMF Number : 28308
Submission : 2014-06-17
Status : Active
Type : II
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Topchem Pharmaceuticals Ltd, based in Ireland, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is TOLCAPONE, with a corresponding US DMF Number 28308.
Remarkably, this DMF maintains an Active status since its submission on June 17, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 15, 2015, and payment made on June 11, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
