01 1Recipharm AB
01 1ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
01 1Sweden
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-19
Pay. Date : 2020-12-10
DMF Number : 35401
Submission : 2020-12-21
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 ROPIVACAINE HYDROCHLORIDE MONOHYDRATE, with a corresponding US DMF Number 35401.
Remarkably, this DMF maintains an Active status since its submission on December 21, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 19, 2021, and payment made on December 10, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
