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Shaily Engineering Plastics Ltd (Shaily), a leading developer and manufacturer of drug delivery systems, announced that its strategic partner Orbicular Pharmaceutical Technologies in partnership with its customer has launched a generic version of semaglutide injection in Canada, incorporating Shaily’s proprietary spring-driven ShailyPen Neo pen platform. The combination product has been commercially available in India since March 2026 and has received US FDA tentative approval.
ShailyPen Neo is among a rare class of commercially available spring-driven pen injectors globally — a high-performance, variable and fixed dose platform offering full compatibility with ISO-standard 3 mL cartridges (3 mL and 1.5 mL fill). Shaily’s role in this programme relates to full design and development, and manufacturing and supply of the device components used in the approved combination product.
It has got regulatory approvals from the USFDA, Health Canada India Central Drug Standards Control Organisation (CDSCO) device platform ShailyPen Neo in variable & fixed dose cartridge format ISO-standard 3 mL and 1.5 mL fill.
“This achievement is one we carry with a great deal of humility. ShailyPen Neo did not happen by accident — spring-driven pen injector technology sits within a highly restricted IP environment, and bringing a platform of this caliber to regulatory approval was never going to be easy. We recognized early that spring-actuated pen injectors would become a critical enabler in injectable therapies and made a genuinely bold bet: full-scale investment from design through to industrial manufacturing. What got us here was not boldness alone — it was patience, precision, and an unshakeable belief in what we were building. I am deeply grateful to our customers who believed in us and chose to build with us — your confidence in Shaily has pushed us to be better at every step. And to every member of the Shaily team who poured their expertise and commitment into this program: you are the reason we are here,” says Amit Sanghvi, managing director, Shaily Engineering Plastics Ltd.
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