01 1ScinoPharm Taiwan Ltd
01 1TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE
01 1Taiwan
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-29
Pay. Date : 2013-09-18
DMF Number : 20810
Submission : 2007-08-22
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 TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE, with a corresponding US DMF Number 20810.
Remarkably, this DMF maintains an Active status since its submission on August 22, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 29, 2013, and payment made on September 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
