01 1Jiangsu Sinopep Allsino Biopharmaceutical
01 1BIVALIRUDIN
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2018-09-19
DMF Number : 32281
Submission : 2018-06-29
Status : Active
Type : II
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Sinopep-allsino Biopharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is BIVALIRUDIN, with a corresponding US DMF Number 32281.
Remarkably, this DMF maintains an Active status since its submission on June 29, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 15, 2019, and payment made on September 19, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
