01 1Raks Pharma
01 1VORTIOXETINE HYDROBROMIDE SOLVATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-18
Pay. Date : 2017-03-28
DMF Number : 31602
Submission : 2017-03-30
Status : Active
Type : II
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Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is VORTIOXETINE HYDROBROMIDE SOLVATE, with a corresponding US DMF Number 31602.
Remarkably, this DMF maintains an Active status since its submission on March 30, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 18, 2017, and payment made on March 28, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
