01 1Zydus Lifesciences
01 1RIFAXIMIN (PROCESS-I)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-06
Pay. Date : 2021-03-26
DMF Number : 35323
Submission : 2020-10-29
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 RIFAXIMIN (PROCESS-I), with a corresponding US DMF Number 35323.
Remarkably, this DMF maintains an Active status since its submission on October 29, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 06, 2021, and payment made on March 26, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
