01 1Hubei Gedian Humanwell Pharmaceutical
01 1NINTEDANIB ESYLATE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-03
Pay. Date : 2018-09-20
DMF Number : 33152
Submission : 2018-09-28
Status : Active
Type : II
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Hubei Chengtian Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
One of their notable products is NINTEDANIB ESYLATE, with a corresponding US DMF Number 33152.
Remarkably, this DMF maintains an Active status since its submission on September 28, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 03, 2018, and payment made on September 20, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
