01 1BDR Lifesciences
01 1OLAPARIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-11-17
Pay. Date : 2025-09-18
DMF Number : 42527
Submission : 2025-09-27
Status : Active
Type : II
20
Bdr Lifesciences Private Ltd, based in India, is a pharmaceutical company.
One of their notable products is OLAPARIB, with a corresponding US DMF Number 42527.
Remarkably, this DMF maintains an Active status since its submission on September 27, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 17, 2025, and payment made on September 18, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
