01 1Aurore Life Sciences
01 1VALACYCLOVIR HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-11
Pay. Date : 2022-02-25
DMF Number : 34743
Submission : 2020-03-20
Status : Active
Type : II
20
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 VALACYCLOVIR HYDROCHLORIDE USP, with a corresponding US DMF Number 34743.
Remarkably, this DMF maintains an Active status since its submission on March 20, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 11, 2022, and payment made on February 25, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
