01 1ScinoPharm Taiwan Ltd
01 1FONDAPARINUX SODIUM USP
01 1Taiwan
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-07
Pay. Date : 2013-09-26
DMF Number : 27563
Submission : 2013-12-30
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 FONDAPARINUX SODIUM USP, with a corresponding US DMF Number 27563.
Remarkably, this DMF maintains an Active status since its submission on December 30, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 07, 2014, and payment made on September 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
