01 1USV Private Limited
01 1ELAGOLIX SODIUM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-04-16
Pay. Date : 2024-03-06
DMF Number : 40326
Submission : 2024-09-30
Status : Active
Type : II
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Usv Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
One of their notable products is ELAGOLIX SODIUM, with a corresponding US DMF Number 40326.
Remarkably, this DMF maintains an Active status since its submission on September 30, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 16, 2025, and payment made on March 06, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
