01 1Fareva
01 1ESTRADIOL HEMIHYDRATE
01 1Luxembourg
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-27
Pay. Date : 2014-04-24
DMF Number : 22972
Submission : 2009-07-21
Status : Active
Type : II
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Valdepharm, based in Luxembourg, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
One of their notable products is ESTRADIOL HEMIHYDRATE, with a corresponding US DMF Number 22972.
Remarkably, this DMF maintains an Active status since its submission on July 21, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 27, 2014, and payment made on April 24, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
