Macco Organiques Sro, based in Czech Republic, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is MAGNESIUM SULFATE HEPTAHYDRATE, with a corresponding US DMF Number 31105.
Remarkably, this DMF maintains an Active status since its submission on November 02, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 27, 2018, and payment made on May 10, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II