01 1Zydus Lifesciences
01 1PROPAFENONE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-12
Pay. Date : 2013-09-25
DMF Number : 25055
Submission : 2011-07-20
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 PROPAFENONE HYDROCHLORIDE USP, with a corresponding US DMF Number 25055.
Remarkably, this DMF maintains an Active status since its submission on July 20, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 12, 2014, and payment made on September 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
