01 1AmbioPharm
01 1TEDUGLUTIDE NON-STERILE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-04
Pay. Date : 2016-08-01
DMF Number : 30583
Submission : 2016-08-12
Status : Active
Type : II
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Ambio Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for The FDA-inspected, USA-based Peptide Manufacturer with the Largest Worldwide Capacity.
One of their notable products is TEDUGLUTIDE NON-STERILE, with a corresponding US DMF Number 30583.
Remarkably, this DMF maintains an Active status since its submission on August 12, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 04, 2016, and payment made on August 01, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
