ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
KEY PRODUCTS
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01 1ICE Pharma
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01 1URSODIOL
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01 1Italy
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01 1Active
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01 1Complete
ICE 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
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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