01 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 1ESTRADIOL HEMIHYDRATE USP, NON-STERILE, BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-26
Pay. Date : 2021-10-22
DMF Number : 23942
Submission : 2010-06-29
Status : Active
Type : II
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Zhejiang Xianju Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ESTRADIOL HEMIHYDRATE USP, NON-STERILE, BULK DRUG SUBSTANCE, with a corresponding US DMF Number 23942.
Remarkably, this DMF maintains an Active status since its submission on June 29, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 26, 2022, and payment made on October 22, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
