Hetero Drugs 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 MICAFUNGIN SODIUM, with a corresponding US DMF Number 40132.
Remarkably, this DMF maintains an Active status since its submission on August 16, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 15, 2024, and payment made on September 05, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II