Shaily Engineering Plastics has achieved a significant regulatory milestone with its generic Semaglutide injection receiving USFDA Tentative Approval, Health Canada Notice of Compliance, and CDSCO approval from India's regulatory body. According to the company's latest press release, this comprehensive regulatory approval enables the commercial launch of the combination product in multiple markets. The product has been commercially available in India since March 2026, demonstrating the platform's proven performance and regulatory compliance across jurisdictions.
Shaily Engineering Plastics has announced that its strategic partner Orbicular Pharmaceutical Technologies has launched a generic version of Semaglutide injection in Canada, incorporating Shaily's proprietary spring-driven ShailyPen Neo pen platform. As reported by the company, this combination product has been commercially available in India since March 2026 and has now secured USFDA Tentative Approval, Health Canada Notice of Compliance, and CDSCO approval from India's regulatory body. The product launch represents a significant achievement in the company's strategic partnership approach.
ShailyPen Neo is described as being among a rare class of commercially available spring-driven pen injectors globally, offering high-performance, variable and fixed dose platform capabilities. The platform provides full compatibility with ISO-standard 3 mL cartridges (3 mL and 1.5 mL fill) and represents a significant technological advancement in pen injector design. According to the company, the platform supports both variable and fixed dose formats, making it versatile for different drug delivery requirements.
According to the company announcement, Shaily's role in this program relates to full design and development, and manufacturing and supply of the device components used in the approved combination product. Managing Director Amit Sanghvi stated that the development reflects the company's long-term investment in spring actuated pen injector technology and large scale industrial manufacturing capabilities. The company operates across healthcare, consumer and engineering plastics segments, with its healthcare business focused on drug delivery systems including pen injectors, autoinjectors and specialty delivery devices.
