Shaily Engineering Plastics has announced the successful regulatory approval and commercial launch of a generic Semaglutide injection using its proprietary ShailyPen Neo™ device platform. Developed in partnership with Orbicular Pharmaceutical Technologies, the spring-driven pen injector has secured USFDA Tentative Approval and Health Canada Notice of Compliance. The product, which is already available in the Indian market as of March 2026, represents a significant milestone for Shaily’s healthcare technology division.
Advancing Drug Delivery Technology
The ShailyPen Neo™ platform is a sophisticated, spring-driven pen injector designed for variable and fixed-dose delivery. By successfully integrating this technology with a generic version of Semaglutide, Shaily Engineering Plastics has demonstrated its capability to operate within highly complex regulatory and intellectual property environments. This project marks a pivotal expansion of the company’s healthcare portfolio, focusing on the growing demand for advanced, user-friendly injectable therapies.
Strategic Partnership and Market Reach
This achievement is the result of a strategic collaboration with Orbicular Pharmaceutical Technologies. Shaily’s role encompassed the full lifecycle of the device, from initial design and development to large-scale industrial manufacturing and component supply. The device is compatible with ISO-standard 3 mL cartridges, offering flexibility for both 3 mL and 1.5 mL fill volumes. The product’s commercialization in Canada and India, coupled with USFDA Tentative Approval, validates the platform’s global potential.
Leadership Perspective
Reflecting on the milestone, Amit Sanghvi, Managing Director of Shaily Engineering Plastics, emphasized the dedication required to bring such technology to fruition. He noted that the company made a full-scale investment in the project, driven by the belief that spring-actuated pens would become a critical enabler in the future of injectable medications. This launch serves as a testament to the company’s commitment to precision engineering and its ability to meet the stringent requirements of international pharmaceutical partners.
Source: BSE
