01 1Roquette
01 1MANNITOL USP GRADE (PEARLITOL PF)
01 1France
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-31
Pay. Date : 2013-07-22
DMF Number : 12879
Submission : 1998-02-26
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 MANNITOL USP GRADE (PEARLITOL PF), with a corresponding US DMF Number 12879.
Remarkably, this DMF maintains an Active status since its submission on February 26, 1998, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 31, 2013, and payment made on July 22, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
