01 1NEWCHEM SPA
01 1BUDESONIDE MICRONIZED
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-19
Pay. Date : 2013-09-03
DMF Number : 25319
Submission : 2011-08-22
Status : Active
Type : II
20
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 BUDESONIDE MICRONIZED, with a corresponding US DMF Number 25319.
Remarkably, this DMF maintains an Active status since its submission on August 22, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 19, 2013, and payment made on September 03, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
