01 1Procos
01 1ISTRADEFYLLINE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-10-24
Pay. Date : 2025-09-05
DMF Number : 38212
Submission : 2023-04-12
Status : Active
Type : II
20
Procos Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ISTRADEFYLLINE, with a corresponding US DMF Number 38212.
Remarkably, this DMF maintains an Active status since its submission on April 12, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2025, and payment made on September 05, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
