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 OSELTAMIVIR PHOSPHATE USP, with a corresponding US DMF Number 30253.
Remarkably, this DMF maintains an Active status since its submission on April 13, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 06, 2016, and payment made on April 08, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II