Shaily announces approval, launch of customer combo product with ShailyPen Neo Device Technology

USFDA Tentative Approval, Health Canada Notice of Compliance, and India CDSCO approval have been secured for a customer's generic semaglutide injection incorporating the ShailyPen Neo Spring-Driven variable and fixed dose pen injector platform

Shaily Engineering Plastics (Shaily), 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 USFDA Tentative Approval.

ShailyPen Neo is reportedly 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.

Commenting on the launch, Amit Sanghvi, Managing Director, Shaily Engineering Plastics said, “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 recognised 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 programme: you are the reason we are here.”

gSemaglutideOrbicular Pharmaceutical TechnologiesShaily Engineering PlasticsShailyPen Neo
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