01 1Zydus Lifesciences
01 1COLESTIPOL HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-20
Pay. Date : 2020-02-06
DMF Number : 33460
Submission : 2019-04-01
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 COLESTIPOL HYDROCHLORIDE USP, with a corresponding US DMF Number 33460.
Remarkably, this DMF maintains an Active status since its submission on April 01, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 20, 2020, and payment made on February 06, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
