Our Capabilities
At the heart of Caplin’s glorious journey has been an impeccable development, manufacturing, and quality infrastructure. The Company has been consistently investing in adding new plants, expanding existing capacity, securing quality manufacturing partnerships and fueling product portfolio expansion and diversification.
Caplin Steriles currently has 25 ANDAs approved, with 18 in our own name and 7 in our partners’ names. Of these, we have launched 21 products with the other 4 to be launched in the coming months. We have 16 ANDAs under review with the FDA, which is a healthy mix of Injectable Suspensions, Emulsions, Ready-To-Use Bags, Ophthalmic solutions and Emulsion. The company has a pipeline of 30+ products under various stages of development that it intends to file over the next 2-3 years.
With our proven performance in simple and complex injectables across development and manufacturing, we are enabled to meet diverse injectable needs. The company has more than doubles its installed capacity in recent times with the activation of Phase 2, and further enhancement of capacities and capabilities is underway with Phase 3 of our plant under construction. The latest expansion would feature high Lyophilization capacities, aseptic filling under Isolator and dedicated fill/finish lines for specific biological products.
