01 1AmbioPharm
01 1EPTIFIBATIDE (NON-STERILE)
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-29
Pay. Date : 2013-05-06
DMF Number : 24864
Submission : 2011-04-18
Status : Active
Type : II
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Ambiopharm 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 EPTIFIBATIDE (NON-STERILE), with a corresponding US DMF Number 24864.
Remarkably, this DMF maintains an Active status since its submission on April 18, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 29, 2013, and payment made on May 06, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
