01 1Intas Pharmaceuticals
01 1CABAZITAXEL (AMORPHOUS)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-28
Pay. Date : 2014-02-19
DMF Number : 27978
Submission : 2014-02-20
Status : Active
Type : II
20
Intas Pharmaceuticals 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 CABAZITAXEL (AMORPHOUS), with a corresponding US DMF Number 27978.
Remarkably, this DMF maintains an Active status since its submission on February 20, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 28, 2014, and payment made on February 19, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
