01 1NEWCHEM SPA
01 1DROSPIRENONE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-04
Pay. Date : 2012-11-27
DMF Number : 22802
Submission : 2009-05-15
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 DROSPIRENONE, with a corresponding US DMF Number 22802.
Remarkably, this DMF maintains an Active status since its submission on May 15, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 04, 2012, and payment made on November 27, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
