Quimica Sintetica Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is OFLOXACIN, with a corresponding US DMF Number 14767.
Remarkably, this DMF maintains an Active status since its submission on March 08, 2000, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 03, 2013, and payment made on December 27, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II