01 1AmbioPharm
01 1LIRAGLUTIDE, NON-STERILE, BULK DRUG SUBSTANCE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-06
Pay. Date : 2018-04-24
DMF Number : 27215
Submission : 2013-06-12
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 LIRAGLUTIDE, NON-STERILE, BULK DRUG SUBSTANCE, with a corresponding US DMF Number 27215.
Remarkably, this DMF maintains an Active status since its submission on June 12, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 06, 2018, and payment made on April 24, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
