01 1Kekule Pharma
01 1NILUTAMIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-18
Pay. Date : 2014-06-17
DMF Number : 25465
Submission : 2011-09-29
Status : Active
Type : II
20
Kekule Pharma Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
They are recognized for Inspired by Life, Driven by Science.
One of their notable products is NILUTAMIDE, with a corresponding US DMF Number 25465.
Remarkably, this DMF maintains an Active status since its submission on September 29, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 18, 2014, and payment made on June 17, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
