01 1Wanbury Limited
01 1PAROXETINE HYDROCHLORIDE HEMIHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-05
Pay. Date : 2016-11-23
DMF Number : 20248
Submission : 2006-12-19
Status : Active
Type : II
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Wanbury Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is PAROXETINE HYDROCHLORIDE HEMIHYDRATE, with a corresponding US DMF Number 20248.
Remarkably, this DMF maintains an Active status since its submission on December 19, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 05, 2017, and payment made on November 23, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
