Shandong Xinhua Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is HYDROCORTISONE, with a corresponding US DMF Number 33073.
Remarkably, this DMF maintains an Active status since its submission on October 04, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 15, 2020, and payment made on October 15, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II