01 1AmbioPharm
01 1BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-30
Pay. Date : 2013-05-16
DMF Number : 20853
Submission : 2007-09-14
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 BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 20853.
Remarkably, this DMF maintains an Active status since its submission on September 14, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 30, 2013, and payment made on May 16, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
