01 1NEWCHEM SPA
01 1DEFLAZACORT
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-11
Pay. Date : 2023-05-19
DMF Number : 38357
Submission : 2023-05-19
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 DEFLAZACORT, with a corresponding US DMF Number 38357.
Remarkably, this DMF maintains an Active status since its submission on May 19, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 11, 2023, and payment made on May 19, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
