Laurus Labs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is LOPINAVIR USP, with a corresponding US DMF Number 33919.
Remarkably, this DMF maintains an Active status since its submission on June 25, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 11, 2019, and payment made on June 10, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II