01 1AmbioPharm
01 1ICATIBANT ACETATE (NON-STERILE)
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-30
Pay. Date : 2015-04-24
DMF Number : 29225
Submission : 2015-05-22
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 ICATIBANT ACETATE (NON-STERILE), with a corresponding US DMF Number 29225.
Remarkably, this DMF maintains an Active status since its submission on May 22, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 30, 2015, and payment made on April 24, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
