Submission of Press Release titled "Shaily Engineering Plastics Limited Announces Regulatory Approval & Launch of Customer Combination Product Incorporating its ShailyPen Neo Device Technology"
SHAILY · price
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Shaily Engineering Plastics announced regulatory approval and commercial launch of a generic Semaglutide injection (for diabetes/weight management) incorporating its proprietary ShailyPen Neo spring-driven pen injector. The combination product has received USFDA Tentative Approval, Health Canada Notice of Compliance, and Indian CDSCO approval. The product is already commercially available in India since March 2026 and launched in Canada through strategic partner Orbicular Pharmaceutical Technologies. ShailyPen Neo is a high-performance variable and fixed dose pen injector compatible with ISO-standard 3 mL cartridges. Shaily handled full design, development, and manufacturing of device components for this program.
This regulatory milestone validates Shaily's proprietary drug delivery technology and positions the company for revenue growth from international pharmaceutical markets. The USFDA and Health Canada approvals expand the company's addressable market beyond India, potentially benefiting shareholders as commercial sales scale up.