01 1Cipla
01 1ENZALUTAMIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-08
Pay. Date : 2020-09-29
DMF Number : 35143
Submission : 2020-09-26
Status : Active
Type : II
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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 ENZALUTAMIDE, with a corresponding US DMF Number 35143.
Remarkably, this DMF maintains an Active status since its submission on September 26, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 08, 2020, and payment made on September 29, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
