01 1Hansoh Pharma
01 1NINTEDANIB ESYLATE, NON-STERILE, BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-24
Pay. Date : 2019-12-02
DMF Number : 34332
Submission : 2019-12-20
Status : Active
Type : II
20
Jiangsu Hansoh Pharmaceutical Group Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is NINTEDANIB ESYLATE, NON-STERILE, BULK DRUG SUBSTANCE, with a corresponding US DMF Number 34332.
Remarkably, this DMF maintains an Active status since its submission on December 20, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2020, and payment made on December 02, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
