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 PIRFENIDONE, with a corresponding US DMF Number 32739.
Remarkably, this DMF maintains an Active status since its submission on May 04, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 03, 2018, and payment made on April 26, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II