01 1Chr. Olesen Synthesis A.S
01 1BUPRENORPHINE HCl USP
01 1Denmark
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-15
Pay. Date : 2021-07-14
DMF Number : 35988
Submission : 2021-07-30
Status : Active
Type : II
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Chr Olesen Synthesis As, based in Denmark, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is BUPRENORPHINE HCl USP, with a corresponding US DMF Number 35988.
Remarkably, this DMF maintains an Active status since its submission on July 30, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 15, 2021, and payment made on July 14, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
