Elite Products Portfolio at a Glance
Generic
Generic of Invega (Paliperidone Extended-Release Tablet)
US FDA Approval 10/29/2020
NMPA Approval 06/07/2023
Generic of Procardia XL (Nifedipine Extended-Release Tablet)
US FDA Approval 11/18/2020
Generic of Tegretol (Carbamazepine Extended-Release Tablet)
US FDA Approval 04/13/2021
Generic of Plaquenil (Hydroxychloroquine Sulfate Tablet)
NMPA Approval 12/21/2021
Generic of Xeljanz (Tofacitinib Extended-Release Tablet)
NMPA Approval 10/18/2022
Generic of Toprol XL (Metoprolol Succinate Extended-Release Tablet)
NMPA Approval 09/30/2021
US FDA Approval 07/26/2024
Generic of Valcyte (Valganciclovir Hydrochloride Tablet)
NMPA Approval 06/28/2024
Under US FDA Review
505 (b)(2)
Project 306: Fixed combination extended-release tablet for type 2 diabetes treatment.
Pre-IND reviewed by FDA, Q3 2024
US FDA IND application. Q3 2025
Project 308: Fixed combination extended-release tablet for type 2 diabetes treatment
Pre-IND reviewed by FDA, Q3 2024
US FDA IND application, Q3 2025
Project 309: Extended-release tablet for type 2 diabetes treatment
IND under review by FDA, Q2 2025
Project 301: Fixed combination extended-release tablet for type 2 diabetes treatment
Pivotal Phase 1 clinical trials, Q2, 2025
US FDA NDA application, Q4 2025