Shaily gets regulatory nod for launch of ShailyPen Neo device technology
Medical Device

Shaily gets regulatory nod for launch of ShailyPen Neo device technology

The product has received tentative USFDA approval, Health Canada notice of compliance, and Indian regulatory approval

  • By IPP Bureau | May 20, 2026
Shaily Engineering Plastics Limited, 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 USFDA tentative approval. 

ShailyPen Neo is among a rare class of commercially available spring-driven pen injectors globally. It is 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 program relates to full design and development, and manufacturing and supply of the device components used in the approved combination product.

Amit Sanghvi, Managing Director, Shaily Engineering Plastics Limited 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 recognized early that spring-actuated pen injectors would become a critical enabler in injectable therapies, and we made a genuinely bold bet."

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