Integrated final dosage capabilities
Every stage of drug development and manufacturing, from the raw API to the final patient dose, demands exceptional control and scientific discipline.
Our formulations facility is designed to manufacture injectables and liquid orals in compliance with the latest FDA and revised Annex 1 guidelines.
Injectable manufacturing
We will have compounding, filling & packing capabilities for vials with pack sizes from 2-30ml and batch sizes of 10–200 Lts. Aseptic filling, terminal sterilization and lyophilization will take place under controlled cleanroom conditions, giving you confidence in product integrity from preparation to release.
Liquid oral manufacturing
Liquid oral production is planned to support 60–1000 L batches with fill volumes from 50 to 500 mL. These capabilities will allow the development of stable solutions and suspensions tailored for clinical or early commercial use, including pediatric and geriatric formulations.
Tech transfer and scale-up
You can expect a controlled, well-documented process that maintains consistency from formulation through manufacturing. Our technical approach is built to support smooth transfer, reliable performance and full compliance at every stage.
Quality and control
Quality underpins every operation. Our new facility is designed to align with FDA and EU expectations, with validation and environmental monitoring integral to the approach.
Extending our reach, strengthening our roots
Construction of the new formulation facility is underway, with pilot operations targeted for 2026 and a commercial site planned for 2028.
These capabilities will strengthen our ability to support clinical and early commercial programs.
