Lusochimica Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is GLIBENCLAMIDE (GLYBURIDE), with a corresponding US DMF Number 9430.
Remarkably, this DMF maintains an Active status since its submission on December 03, 1991, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 06, 2013, and payment made on May 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II