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 CALCIUM CHLORIDE DIHYDRATE USP, with a corresponding US DMF Number 14996.
Remarkably, this DMF maintains an Active status since its submission on August 15, 2000, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2014, and payment made on July 02, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II