Zydus Life Science , a prominent innovation-driven life sciences company, has announced significant milestones in its medical technology and pharmaceutical portfolios. The company's proprietary robotic surgical system, 'Andy', has received CE mark approval, confirming its compliance with European standards for safety, performance, and quality. Additionally, Zydus has secured final USFDA approval for Diroximel Fumarate Delayed-Release Capsules, a treatment for relapsing multiple sclerosis. In a recent development, the company also completed a US FDA inspection at its oncology injectable manufacturing facility.

Key Highlights

• Zydus' surgical robot 'Andy' has been granted CE mark approval, opening up market opportunities in the European Union.
• 'Andy' combines navigation technology with robotic assistance capabilities.
• The system is built on Amplitude's proprietary navigation platform, Amplivision.
• The CE-marked solution integrates Amplitude's navigation technology with robotic assistance, developed through a strategic collaboration with eCential Robotics.
• Zydus received final USFDA approval for Diroximel Fumarate Delayed-Release Capsules, 231 mg, for treating relapsing multiple sclerosis.
• The multiple sclerosis treatment has expected annual sales of USD 999.40 million in the US market.
• The US FDA conducted a Pre-Approval Inspection at Zydus Lifesciences' SEZ Oncology Injectable manufacturing site in Ahmedabad.

Implications for Orthopaedic Innovation

The CE mark approval for 'Andy' represents a significant advancement in orthopaedic surgery. Conceived as a collaborative robot, Andy is designed to perform bone resections with precision and reliability. This innovation aims to empower surgeons with greater confidence in the operating room and sets a new benchmark for robot-assisted procedures across Europe.

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Ltd., commented on this development, stating, "This milestone reflects our commitment to innovation that is both patient-centric and future-ready. Andy represents a convergence of science, healthcare, and technology."

Potential Benefits for Patients

The Andy robotic surgical system is expected to deliver several benefits:

• Enhanced accuracy and consistency in surgical procedures
• Optimal alignment while minimizing tissue trauma
• Potential for smaller incisions, reduced pain, and faster recovery
• Fewer complications
• Improved knee function
• Shorter hospital stays
• Ensured long-term implant performance

Strategic Expansion in MedTech and Pharmaceuticals

The CE mark approval for 'Andy' follows Zydus MedTech's expansion of its global presence through the strategic acquisition of Amplitude Surgical, a European MedTech company specializing in high-quality lower-limb orthopaedic technologies. The acquisition strengthens Zydus MedTech's commitment to delivering advanced, patient-focused solutions through cutting-edge research, design innovation, and precision engineering.

Furthermore, the USFDA approval for Diroximel Fumarate Delayed-Release Capsules demonstrates Zydus' continued success in the pharmaceutical sector, particularly in addressing neurological disorders such as multiple sclerosis. This approval opens up a significant market opportunity for Zydus in the United States.

US FDA Inspection of Oncology Injectable Facility

The US FDA conducted a Pre-Approval Inspection at Zydus Lifesciences' SEZ Oncology Injectable manufacturing site in Ahmedabad. The inspection concluded with two observations and no data integrity issues. Zydus has stated that it will work with the FDA to address these observations expeditiously as part of the approval process for their new isolator injectable line.

Looking Ahead

The CE mark approval for 'Andy' positions Zydus Lifesciences to capitalize on the growing demand for advanced surgical technologies in the European market. As the company continues to innovate in the medical technology space, this development marks a significant step in its journey to become a leading player in the global orthopaedic robotics market.

Simultaneously, the USFDA approval for the multiple sclerosis treatment strengthens Zydus' position in the US pharmaceutical market, with potential for substantial revenue generation.

The recent FDA inspection of the oncology injectable facility, while resulting in two observations, demonstrates the company's commitment to maintaining high standards in its manufacturing processes. The successful resolution of these observations will be crucial for the approval of Zydus' new isolator injectable line.

For Zydus Lifesciences, these developments not only validate their technological and pharmaceutical capabilities but also align with their mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The company's focus will likely be on the successful commercialization of 'Andy' in the European market, the multiple sclerosis treatment in the US market, and addressing the FDA observations to ensure smooth approval for their oncology injectable line.

Zydus Life Science , a leading pharmaceutical company, has reported strong financial results for the second quarter ended September 30, 2025, demonstrating significant growth across key business segments.

Financial Highlights

The company delivered consolidated revenues of Rs 61.20 billion, marking a 17% year-on-year increase. Notably, the EBITDA margin improved to 32.90%, a substantial increase of 500 basis points year-on-year. EBITDA stood at Rs 20.20 billion, up 38%, while net profit rose to Rs 12.60 billion, also up 38% compared to the same period last year.

Segment Performance

US Formulations Business

The US formulations business grew 14% to Rs 27.40 billion, driven by volume expansion and new product launches. During the quarter, Zydus filed six ANDAs, received four approvals (including one tentative approval), and launched seven new products.

India Branded Formulations

The branded formulations business in India grew 9% year-on-year, outpacing market growth. The chronic segment continued to drive overall growth, with the company showing faster-than-market growth in key therapies such as cardiology, gynecology, and oncology.

International Markets

The international markets formulations business posted revenues of Rs 7.50 billion, showing strong year-on-year growth of 39%. This growth was broad-based across regions, with robust demand-driven performance in both emerging markets and Europe.

Consumer Wellness

The consumer wellness business recorded revenues of Rs 6.40 billion, up 31% year-on-year. This segment was bolstered by the acquisition of UK-based Comfort Click Limited (CCL), a digital consumer healthcare platform specializing in vitamins, minerals, and supplements.

Key Developments

1. Specialty Portfolio Expansion: In October 2025, Zydus launched Beizray, an albumin-solubilized docetaxel injection, strengthening its 505(b)(2) portfolio in the US market.

2. International Acquisition: The company made its first international acquisition by acquiring Comfort Click Limited, significantly strengthening its presence in key markets of the UK, EU, and the US in the fast-growing vitamins, minerals, and supplements space.

3. Vaccine Innovation: Zydus launched VaxiFlu, India's first trivalent influenza vaccine for flu protection, aligning with global WHO recommendations.

4. Clinical Trial Success: The company reported positive top-line results from the Pivotal EPICS-III Phase 2(b)/3 trial of Saroglitazar Magnesium for Primary Biliary Cholangitis (PBC) in the US market. Zydus is on track to file the new drug application with the US FDA in Q4 FY26.

5. MedTech Expansion: Zydus completed the acquisition of Amplitude Surgical, strengthening its position in the orthopedics space.

Future Outlook

Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, commented on the results: "We are pleased with our performance during the quarter and the first half of fiscal '26. The business continued to demonstrate strong growth momentum driven by consistent performance across segments and underpinned by robust operating profitability. We remain committed to accelerating innovation that drives our long-term growth across our businesses."

The company is focusing on expanding its presence in specialty pharmaceuticals, particularly in the US market, and is exploring strategic opportunities in international markets. Zydus is also making strides in the MedTech sector, with plans to expand in focused areas of orthopedics, nephrology, and cardiology.

With a strong pipeline of products and a focus on innovation, Zydus Lifesciences appears well-positioned for sustained growth in the coming quarters.