KEY PRODUCTS
AMI Lifesciences is Driven by Chemistry. Powered by People.
01 1Ami Lifesciences Private Limited
01 1VIBEGRON
01 1India
01 1Active
01 1Complete
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-31
Pay. Date : 2024-06-13
DMF Number : 39538
Submission : 2024-03-21
Status : Active
Type : II
20
Ami Lifesciences Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for AMI Lifesciences is Driven by Chemistry. Powered by People.
One of their notable products is VIBEGRON, with a corresponding US DMF Number 39538.
Remarkably, this DMF maintains an Active status since its submission on March 21, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 31, 2024, and payment made on June 13, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
