Product Development and Commercial Supply
We offer one-stop solution to our customer’s need for sterile injectables.
Our R&D team can develop solution and lyophilized injections incorporating QbD principles. We can execute scale up and exhibit batches, conduct stability studies, assist in the compilation of ANDAs/dossiers, and most importantly, be your reliable supplier during the commercial supply phase.
Technology Transfer for Commercial Supply
We have significant experience with Technology transfer and Site transfer (CBE-30) projects.
If you are looking for a manufacturing site for an approved ANDA or Market Authorization you own, or if you have developed a product at lab scale and need a manufacturing partner, we are eager to support you.
We have significant experience with Technology transfer and Site transfer (CBE-30) projects. We have successfully completed numerous projects for US, Canada, and other markets. We work with you for method transfer, scale up/exhibit batches, and regulatory filings followed by commercial supply.
Though our primary focus is on CDMO, we have partnered with our existing customers to co-develop and license products. We develop a few products which we also license to customers in various geographies. Please contact us to discuss co-development/licensing opportunities.