Please Wait
Applying Filters...
Menu
Xls
Filters Filter
Cross PopUp
FILTER :

filter clear-filterReset all filters

01 1ICE Pharma

filter clear-filterReset all filters

filter clear-filterReset all filters

filter clear-filterReset all filters

filter clear-filterReset all filters

PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

GDUFA

DMF Review : Complete

Rev. Date : 2019-03-25

Pay. Date : 2019-02-14

DMF Number : 16803

Submission : 2003-09-03

Status : Active

Type : II

ICE S.p.A

Looking for Drug Master Files (DMF) for 16803 of Ice Spa

Looking for Drug Master Files (DMF) for 16803 of Ice Spa 1

20

Ice Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

One of their notable products is URSODIOL, with a corresponding US DMF Number 16803.

Remarkably, this DMF maintains an Active status since its submission on September 03, 2003, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 25, 2019, and payment made on February 14, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II