Zydus Lifesciences Limited has announced plans to launch its innovative Semaglutide injection on Day 1 of patent expiry in India, introducing a groundbreaking drug delivery system that promises to transform diabetes and obesity treatment accessibility.

Strategic Launch with Novel Technology

The company will launch Semaglutide injection under three distinct brand names - SEMAGLYN™, MASHEMA™, and ALTERME™. The Drug Controller General of India (DCGI) has already approved the manufacturing and marketing of Semaglutide injection for treating Type 2 Diabetes Mellitus and Obesity.

Innovative Drug Delivery System

Zydus has developed a critical differentiator through its novel, indigenously developed drug-delivery system. Unlike existing treatments requiring patients to purchase multiple single-dose pens during dosage titration, the company's innovative adjustable single-pen device allows patients to select and administer varying dose strengths from a single unit.

This technology significantly enhances patient adherence, maximizes convenience, and drastically reduces overall therapy costs. The company holds exclusive rights to this novel device, which can deliver all approved strengths for Type 2 Diabetes Mellitus and Obesity treatment.

Market Impact and Health Statistics

The launch addresses significant health concerns in India's diabetes and obesity landscape. According to the International Diabetes Federation, India has 8.9 crore adults with diabetes, representing 10.5% of the total adult population.

Leadership Perspective

Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, emphasized the patient-centric innovation approach: "We are not just planning to bring a critical therapy to market, we are aiming to elevate the standard of care. By introducing a first-of-its-kind drug delivery mechanism in India, we plan to simplify the treatment."

The reusable pen design brings greater affordability for patients while maintaining the convenience of seamless dose adjustment, driving better long-term adherence and improved clinical outcomes.

Source: None/Company/INE010B01027/0cf9c309-f61f-4deb-bf9a-17c19047e3ec.pdf

Zydus Lifesciences Limited has successfully completed a US Food and Drug Administration (USFDA) Pre Approval Inspection at its Injectable Medical Devices manufacturing facility with zero regulatory observations. The inspection represents a significant milestone for the pharmaceutical company's compliance with international manufacturing standards.

Inspection Details

The USFDA conducted a comprehensive Pre Approval Inspection (PAI) for Injectable Medical Devices at the company's Unit 9 facility. The inspection took place at Zydus Biotech Park, located in Changodar, Ahmedabad, over a four-day period from February 16 to 19, 2026.

Regulatory Significance

The inspection closure with NIL observations indicates that the facility met all USFDA regulatory requirements and manufacturing standards. This outcome demonstrates the company's adherence to Good Manufacturing Practices (GMP) and quality control measures required for pharmaceutical manufacturing operations targeting the US market.

Pre Approval Inspections are critical regulatory assessments conducted by the USFDA to evaluate manufacturing facilities before approving products for the US market. A clean inspection with zero observations is considered a positive regulatory outcome that can facilitate product approvals and market access.

Regulatory Disclosure

Zydus Lifesciences Limited made this announcement as a mandatory disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company formally notified both BSE Limited and the National Stock Exchange of India Limited about the inspection outcome on February 19, 2026.

The successful inspection outcome strengthens the company's regulatory standing and supports its manufacturing capabilities for injectable medical devices intended for international markets, particularly the United States.