01 1Zydus Lifesciences
01 1APREMILAST
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-10
Pay. Date : 2017-12-07
DMF Number : 32223
Submission : 2017-11-30
Status : Active
Type : II
20
Zydus Lifesciences 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 APREMILAST, with a corresponding US DMF Number 32223.
Remarkably, this DMF maintains an Active status since its submission on November 30, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 10, 2018, and payment made on December 07, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
