Zydus Lifesciences Gains USFDA Approval for Ahmedabad Plant and Aflibercept Biosimilar Launch
**Zydus Lifesciences Market Brief**
**February 20, 2026**
Zydus Lifesciences is witnessing a surge in institutional interest following a dual breakthrough in regulatory compliance and product innovation. The company successfully concluded a USFDA Pre-Approval Inspection at its Unit 9 injectable facility in Ahmedabad on February 19, 2026.
The inspection ended with **zero observations**, a critical "Nil" status that paves the way for accelerated approvals in the high-margin US injectable market. This compliance milestone reinforces Zydus’s manufacturing standards after its oncology facility was upgraded to VAI status late last year.
Simultaneously, Zydus has launched **ANYRA**, India’s first indigenous Aflibercept biosimilar. Developed in collaboration with Regeneron and Bayer, this 2 mg therapy targets retinal disorders including neovascular Age-related Macular Degeneration and Diabetic Retinopathy.
The market opportunity for ANYRA is vast. India currently hosts over **100 million** people living with diabetes, with an estimated **7 to 8 million** suffering from diabetic retinopathy. The launch positions Zydus to lead the domestic retinal therapy segment, which requires chronic, long-term treatment.
Financial performance remains robust. For the quarter ended December 31, 2025 (Q3 FY26), Zydus reported consolidated revenue of **₹68,645 million**, marking a significant **30.3%** year-on-year increase. EBITDA for the same period climbed **31%** to **₹18.20 billion**, with margins strengthening to **26.5%**.
The North America business contributed **₹28,000 million** to the quarterly revenue, up **16%** year-on-year. This was supported by **8 new approvals** and **4 product launches** during the quarter, including BEIZRAY, the company’s first oncology 505(b)(2) product.
In the domestic market, the India Branded Formulations segment grew by **14%**, outperforming general market trends. The chronic therapy portfolio now accounts for **45.3%** of this segment, highlighting a strategic shift toward more resilient and recurring revenue streams.
As of February 20, 2026, Zydus Lifesciences (NSE: ZYDUSLIFE) is trading near **₹902**, with a market capitalization of approximately **₹90,800 crore**. The stock maintains a price-to-earnings (P/E) ratio of **18.4**, reflecting a valuation discount compared to several large-cap peers.
Analysts maintain a cautious but positive outlook with a median 12-month price target near **₹1,020**. The focus now shifts to the launch of Saroglitazar Magnesium in the US and the expansion of the biologics portfolio, which currently features more than **13 biosimilars**.