01 1Orchid Pharma
01 1QUETIAPINE FUMARATE (NON STERILE BULK API)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-21
Pay. Date : 2014-03-25
DMF Number : 23292
Submission : 2009-12-24
Status : Active
Type : II
20
Orbion Pharmaceuticals Private 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 QUETIAPINE FUMARATE (NON STERILE BULK API), with a corresponding US DMF Number 23292.
Remarkably, this DMF maintains an Active status since its submission on December 24, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 21, 2014, and payment made on March 25, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
