01 1Roquette
01 1SORBITOL POWDER PYROGEN FREE
01 1France
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-30
Pay. Date : 2024-09-05
DMF Number : 34930
Submission : 2020-06-09
Status : Active
Type : II
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Roquette Freres, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is SORBITOL POWDER PYROGEN FREE, with a corresponding US DMF Number 34930.
Remarkably, this DMF maintains an Active status since its submission on June 09, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 30, 2024, and payment made on September 05, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
