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 TACROLIMUS USP (PROCESS II), with a corresponding US DMF Number 39573.
Remarkably, this DMF maintains an Active status since its submission on March 21, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 04, 2024, and payment made on May 14, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II