
Reset all filters
01 1Cipla
Reset all filters
01 1APREMILAST
Reset all filters
01 1India
Reset all filters
01 1Active
Reset all filters
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-20
Pay. Date : 2017-08-23
DMF Number : 32003
Submission : 2017-09-28
Status : Active
Type : II
20
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 APREMILAST, with a corresponding US DMF Number 32003.
Remarkably, this DMF maintains an Active status since its submission on September 28, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 20, 2017, and payment made on August 23, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II