01 1ScinoPharm Taiwan Ltd
01 1BIVALIRUDIN
01 1Taiwan
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-16
Pay. Date : 2015-08-20
DMF Number : 25634
Submission : 2011-12-27
Status : Active
Type : II
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Scinopharm Taiwan Ltd, based in Taiwan, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for A leading process R&D and API Manufacturing service provider to the Global Pharmaceutical Industry.
One of their notable products is BIVALIRUDIN, with a corresponding US DMF Number 25634.
Remarkably, this DMF maintains an Active status since its submission on December 27, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 16, 2015, and payment made on August 20, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
