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01 1ICE Pharma

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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 : 2025-11-04

Pay. Date : 2025-09-15

DMF Number : 31188

Submission : 2016-11-21

Status : Active

Type : II

ICE S.p.A

Looking for Drug Master Files (DMF) for 31188 of Ice Spa

Looking for Drug Master Files (DMF) for 31188 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 CHENODEOXYCHOLIC ACID, with a corresponding US DMF Number 31188.

Remarkably, this DMF maintains an Active status since its submission on November 21, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 04, 2025, and payment made on September 15, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II