Mumbai: Shaily Engineering Plastics has announced key regulatory milestones for a customer combination product incorporating its proprietary ShailyPen Neo device technology, marking a significant development in the injectable drug delivery segment.
The announcement from Shaily Engineering Plastics confirms that the generic Semaglutide injection incorporating the ShailyPen Neo spring-driven pen injector platform has secured USFDA Tentative Approval, Health Canada Notice of Compliance, and regulatory approval from India’s CDSCO.
According to Shaily Engineering Plastics, its strategic partner Orbicular Pharmaceutical Technologies, in partnership with its customer, has commercially launched the generic Semaglutide injection in Canada.
The product incorporates the company’s proprietary ShailyPen Neo platform. Shaily Engineering Plastics also stated that the combination product has already been commercially available in India since March 2026.
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The Shaily Engineering Plastics announcement highlighted that ShailyPen Neo belongs to a rare class of commercially available spring-driven pen injectors globally.
The platform supports both variable and fixed dose delivery and is fully compatible with ISO-standard 3 mL cartridges, including 3 mL and 1.5 mL fill formats.
Shaily Engineering Plastics said its role in the program included the complete design and development of the device platform, along with manufacturing and supply of the device components used in the approved combination product.
The company emphasized that the approvals further validate the capabilities of the ShailyPen Neo platform in regulated international markets.
The regulatory approvals secured by Shaily Engineering Plastics include:
- USFDA Tentative Approval
- Health Canada Notice of Compliance
- India CDSCO Approval
The approved device platform from Shaily Engineering Plastics supports:
- Variable dose pen injector functionality
- Fixed dose pen injector functionality
- ISO-standard 3 mL cartridge compatibility
- 1.5 mL fill support
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Commenting on the milestone, Amit Sanghvi, Managing Director of 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 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.”
He further added: “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.”
Shaily Engineering Plastics stated that the ShailyPen Neo Spring-Driven Variable & Fixed Dose Pen Injector platform has been developed to support the growing demand for advanced injectable therapies and high-performance drug delivery systems across global healthcare markets.
