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 CALCIUM L-5-METHYLTETRAHYDROFOLATE USP, with a corresponding US DMF Number 26531.
Remarkably, this DMF maintains an Active status since its submission on March 12, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2014, and payment made on April 03, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II