01 1Recipharm AB
01 1DEXMEDETOMIDINE HCL
01 1Sweden
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-17
Pay. Date : 2014-04-09
DMF Number : 26984
Submission : 2013-03-12
Status : Active
Type : II
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Edmond Pharma Srl, based in Sweden, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Recipharm has the brightest minds in the CDMO industry, from early development to commercial manufacturing.
One of their notable products is DEXMEDETOMIDINE HCL, with a corresponding US DMF Number 26984.
Remarkably, this DMF maintains an Active status since its submission on March 12, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 17, 2014, and payment made on April 09, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
