01 1NEWCHEM SPA
01 1ULIPRISTAL ACETATE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-23
Pay. Date : 2018-05-18
DMF Number : 32234
Submission : 2017-11-17
Status : Active
Type : II
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Newchem Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ULIPRISTAL ACETATE, with a corresponding US DMF Number 32234.
Remarkably, this DMF maintains an Active status since its submission on November 17, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 23, 2019, and payment made on May 18, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
