01 1ACS DOBFAR SPA
01 1CEPHALEXIN MONOHYDRATE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2017-02-27
DMF Number : 13612
Submission : 1998-09-01
Status : Active
Type : II
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Acs Dobfar Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is CEPHALEXIN MONOHYDRATE, with a corresponding US DMF Number 13612.
Remarkably, this DMF maintains an Active status since its submission on September 01, 1998, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 17, 2017, and payment made on February 27, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
