Shandong New Time Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is MILRINONE, USP, with a corresponding US DMF Number 35346.
Remarkably, this DMF maintains an Active status since its submission on March 12, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 30, 2021, and payment made on March 19, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II