01 1Aurore Life Sciences
01 1OXCARBAZEPINE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-18
Pay. Date : 2023-09-27
DMF Number : 34484
Submission : 2019-12-31
Status : Active
Type : II
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Aurore Life Sciences Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for An integrated company with complete control of key starting materials, advanced intermediates & high-quality APIs.
One of their notable products is OXCARBAZEPINE USP, with a corresponding US DMF Number 34484.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 18, 2023, and payment made on September 27, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
