01 1USV Private Limited
01 1ETELCALCETIDE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-07
Pay. Date : 2021-03-24
DMF Number : 35768
Submission : 2021-07-22
Status : Active
Type : II
20
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 ETELCALCETIDE HYDROCHLORIDE, with a corresponding US DMF Number 35768.
Remarkably, this DMF maintains an Active status since its submission on July 22, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 07, 2021, and payment made on March 24, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
