Quimica Sintetica Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is ACYCLOVIR, with a corresponding US DMF Number 8584.
Remarkably, this DMF maintains an Active status since its submission on May 25, 1990, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 07, 2014, and payment made on January 29, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II