01 1Aurore Life Sciences
01 1INDOMETHACIN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-11
Pay. Date : 2022-03-31
DMF Number : 36761
Submission : 2022-02-03
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 INDOMETHACIN USP, with a corresponding US DMF Number 36761.
Remarkably, this DMF maintains an Active status since its submission on February 03, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 11, 2022, and payment made on March 31, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
