Lupin Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is DROSPIRENONE USP, with a corresponding US DMF Number 23397.
Remarkably, this DMF maintains an Active status since its submission on January 12, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 27, 2012, and payment made on November 26, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II