01 1Hubei Gedian Humanwell Pharmaceutical
01 1PROGESTERONE (PROCESS II)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-11
Pay. Date : 2021-01-12
DMF Number : 33003
Submission : 2018-07-25
Status : Active
Type : II
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Hubei Gedian Humanwell 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 PROGESTERONE (PROCESS II), with a corresponding US DMF Number 33003.
Remarkably, this DMF maintains an Active status since its submission on July 25, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 11, 2021, and payment made on January 12, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
