Shaily Engineering Plastics secures USFDA, Canada nod for ShailyPen Neo
Shaily Engineering Plastics announced that its strategic partner Orbicular Pharmaceutical Technologies launched a generic Semaglutide injection in Canada using the ShailyPen Neo platform. The product secured USFDA Tentative Approval, Health Canada Notice of Compliance, and Indian CDSCO approval. The ShailyPen Neo is a spring-driven, variable and fixed dose pen injector compatible with ISO-standard 3 mL cartridges.

*this image is generated using AI for illustrative purposes only.
Shaily Engineering Plastics has announced that its strategic partner, Orbicular Pharmaceutical Technologies, has launched a generic version of Semaglutide injection in Canada. This launch incorporates Shaily’s proprietary spring-driven ShailyPen Neo™ pen platform. The combination product has been commercially available in India since March 2026 and has secured USFDA Tentative Approval, along with a Notice of Compliance from Health Canada and approval from the Indian CDSCO.
Regulatory Approvals and Platform Details
The ShailyPen Neoâ„¢ platform is a high-performance, variable and fixed dose pen injector. It offers full compatibility with ISO-standard 3 mL cartridges, supporting both 3 mL and 1.5 mL fill volumes. Shaily Engineering Plastics was responsible for the full design, development, manufacturing, and supply of the device components used in the approved combination product.
| Regulatory Approvals | Device Platform | Cartridge Format |
|---|---|---|
| USFDA TA • Health Canada • India CDSCO | ShailyPen Neo™ • Variable & Fixed Dose | ISO 3 mL • 1.5 mL fill |
Strategic Significance
Amit Sanghvi, Managing Director of Shaily Engineering Plastics, highlighted that spring-driven pen injector technology operates within a highly restricted IP environment. He noted that bringing this platform to regulatory approval required significant investment in design and industrial manufacturing. The company focuses on developing complex drug delivery systems, including pen injectors and autoinjectors, for global pharmaceutical markets.
Historical Stock Returns for Shaily Engineering Plastics
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -2.08% | -3.52% | +46.43% | +8.79% | +50.75% | +567.62% |
When does Shaily Engineering Plastics expect to convert its USFDA Tentative Approval into a full approval, and what milestones or patent expirations are required to trigger a US market launch?
How might Shaily's ShailyPen Neoâ„¢ platform be positioned to capture additional GLP-1 drug partnerships beyond Semaglutide, given the growing pipeline of obesity and diabetes injectables?
What is the estimated market size opportunity for Shaily in Canada and the US combined, and how significantly could this impact the company's revenue mix over the next 2-3 years?


































