01 1Chemi SpA
01 1MESALAMINE USP
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-11-19
DMF Number : 11951
Submission : 1996-04-29
Status : Active
Type : II
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Chemi Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is MESALAMINE USP, with a corresponding US DMF Number 11951.
Remarkably, this DMF maintains an Active status since its submission on April 29, 1996, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 27, 2012, and payment made on November 19, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
