Cipla 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 DOLUTEGRAVIR SODIUM PROCESS A, with a corresponding US DMF Number 34115.
Remarkably, this DMF maintains an Active status since its submission on November 15, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 25, 2019, and payment made on December 11, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II