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Looking for Drug Master Files (DMF) for 27647 of Procos Spa

Looking for Drug Master Files (DMF) for 27647 of Procos Spa 1

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 DALFAMPRIDINE, with a corresponding US DMF Number 27647.

Remarkably, this DMF maintains an Active status since its submission on October 15, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 26, 2014, and payment made on November 20, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II