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 CARBIDOPA, with a corresponding US DMF Number 27430.
Remarkably, this DMF maintains an Active status since its submission on July 23, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 20, 2018, and payment made on December 04, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II