Patheon Api Manufacturing Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is LATANOPROST, with a corresponding US DMF Number 25924.
Remarkably, this DMF maintains an Inactive status since its submission on March 30, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 21, 2014, and payment made on September 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II