01 1Dipharma
01 1SAPROPTERIN DIHYDROCHLORIDE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-04
Pay. Date : 2013-09-23
DMF Number : 26682
Submission : 2012-12-06
Status : Active
Type : II
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Dipharma Sa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is SAPROPTERIN DIHYDROCHLORIDE, with a corresponding US DMF Number 26682.
Remarkably, this DMF maintains an Active status since its submission on December 06, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 04, 2014, and payment made on September 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
