01 1AmbioPharm
01 1GLATIRAMER ACETATE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-06-09
DMF Number : 26489
Submission : 2012-09-27
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 GLATIRAMER ACETATE, with a corresponding US DMF Number 26489.
Remarkably, this DMF maintains an Active status since its submission on September 27, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2015, and payment made on June 09, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
