Redefining Drug Delivery for Speed, Convenience and Precision
Tenshi Kaizen has created the InstaPill® ODT technology to bring advanced manufacturing science to the oral dose form and make it accessible to more brands and patients with a flexible CDMO business model.
Supported by robust R&D, scalable advanced manufacturing, clinical and regulatory expertise. InstaPill® offers truly patient-centric medicines to pharmaceutical brands seeking differentiation by meeting unmet patient needs with a simple regulatory pathway.
Strategic Expertise
Instapill® is transforming orally disintegrating tablet development with Quality by Design. It offers proven taste masking and advanced manufacturing solutions. Clinical, regulatory and IP expertise further strengthen its approach.
Our competitive, comprehensive feasibility programs include Reference Listed Drug dissolution profiling which guides the Regulatory and Development strategy which can include pilot & pivotal bioequivalence studies and freedom to operate / patentability opinions on prototype formulations.
Our deep expertise and collaborative approach empower partners to make informed decisions backed by a strategic, well-planned development pathway driving efficiency, minimizing risk and accelerating time to market for maximum commercial success.
Regulatory Expertise
Regulatory expertise including 505(b)(2) pathways, for accelerated market entry.
Lifecycle Management
Lifecycle management strategies to differentiate and extend brand presence.
Broad Applications
Proprietary ODT technology tailored to a broad range of therapeutic classes.
CDMO Services
End to end CDMO services for customized formulation and scalable production.
Technical Acumen
With a strong foundation in taste masking, formulation science, lyophilisation engineering, cGMP compliance: we deliver high-quality gelatin-free freeze-dried orally disintegrating tablets (ODTs) that enhance patient compliance.
Combining formulation excellence with lyophilization process, we ensure we develop and validate robust processes and stable formulations. The application of precision engineering and automation ensures consistent, high-quality production.
Our strong focus on regulatory and cGMP compliance results a high level of inspection and readiness for all agency and customer audits while our scalability and tech transfer expertise ensures success in product development and commercialisation.
Advanced Techniques
Advanced techniques like freeze dry microscopy, particle size analysis for suspension evaluation and dissolution. Dissolution studies for matching in-vivo performance.
Taste Masking
Expertise in taste masking with novel excipients for patient friendly, low excipient formulations. Electronic tongue ensures palatability and compliance content for taste masking.
Stability
Products with superior moisture control and enhanced stability for reliable performance.
Clinical & Regulatory Support
Comprehensive documentation for seamless approvals in global markets.
Advanced Manufacturing
A fully integrated, automated line ensures minimal manual handling of product and packaging delivering consistently high aesthetic and functional quality in line with global standards.
Commercial batch manufacturing from suspension formulation to palletisation of serialised finished products is completed within approximately 24 hours, supporting maximum shelf-life at release.
Integrated in-process controls, electronic logbooks, and electronic batch records enable the highest levels of data integrity, cGMP alignment and regulatory compliance.
Fully Automated Facilities
High cGMP compliance in India.
End-to-End Integration
Streamlined processes from production to packaging.
Automation with AGVs
Auto-guided vehicle systems for loading and unloading blister trays, minimising human intervention.
Ability to scale
We have a capacity of 300 million ODTs which is set to scale up to 500 million ODTs.
Tailored Support, Every Step of the Way
Whether you need a full-service development of a 505(b)(2) novel formulation with BE studies and eCTD or Tech Transfer of an existing gelatin based oral lyophilisate formulation we provide all of the technical expertise and project management support that you need for success.