01 1ScinoPharm Taiwan Ltd
01 1RILUZOLE USP
01 1Taiwan
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-23
Pay. Date : 2021-10-28
DMF Number : 15252
Submission : 2001-01-16
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 RILUZOLE USP, with a corresponding US DMF Number 15252.
Remarkably, this DMF maintains an Active status since its submission on January 16, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 23, 2023, and payment made on October 28, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
