Biocon Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is DAPAGLIFLOZIN, with a corresponding US DMF Number 31762.
Remarkably, this DMF maintains an Active status since its submission on July 03, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 01, 2017, and payment made on June 14, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II