Zydus Lifesciences has received the Establishment Inspection Report (EIR) from the USFDA for a GMP follow-up inspection conducted at its injectable facility located at Jarod, Vadodara from 25 August to 05 September 2025 and classifying the facility as Voluntary Action Indicated (VAI). This inspection was conducted following the Warning Letter issued on 29 August 2024 by the USFDA. Powered by Capital Market - Live News

Zydus Lifesciences has entered into an exclusive licensing and commercialization agreement with RK Pharma Inc of the US for a novel sterile injectable 505(b)(2) oncology supportive care product for the US market. Under the terms of this agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US. The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and will provide a formulation that is intended to provide reduced dosing error and enhanced compliance of healthcare professionals.Powered by Capital Market - Live News

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial (USRLD: Lupron Injection�, 1 mg/0.2 mL). Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer. Leuprolide Acetate injections will be manufactured at the Company`s oncology injectable manufacturing facility at SEZ1, Ahmedabad (`ALIDAC`). Leuprolide Acetate injection had annual sales of USD 69 mn in the United States (IQVIA MAT Sept 2025). Powered by Capital Market - Live News

Zydus Lifesciences has received approval from the National Medical Products Administration (NMPA), China for Venlafaxine Extended-Release (ER) Capsules, 75 mg and 150 mg. Venlafaxine ER Capsules are indicated for the treatment of Major Depressive Disorder (MDD), Generalised Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD). They help restore the balance of serotonin and norepinephrine in the brain to improve mood and reduce anxiety. Venlafaxine ER Capsules will be produced at Zydus` manufacturing facility at Moraiya, Ahmedabad. This is the first approval that the Group has received from NMPA in China. Powered by Capital Market - Live News

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Olaparib Tablets, 100 mg and 150 mg (USRLD: Lynparza Tablets, 100 mg and 150 mg). Olaparib is indicated for treatment of certain types of ovarian, breast, pancreatic, and prostate cancers in patients who have specific genetic mutations (specifically in the BRCA gene or other homologous recombination repair [HRR] genes). Olaparib tablets will be produced at Zydus Lifesciences Ltd, SEZ. Olaparib tablets had annual sales of USD 1,379.4 mn in the United States (IQVIA MAT Sept-2025). Powered by Capital Market - Live News