01 1Chemi SpA
01 1MESALAMINE CRYSTALLIZED, USP
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-12
Pay. Date : 2013-04-11
DMF Number : 25385
Submission : 2011-10-13
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 CRYSTALLIZED, USP, with a corresponding US DMF Number 25385.
Remarkably, this DMF maintains an Active status since its submission on October 13, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 12, 2013, and payment made on April 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
