Caplin Steriles

Caplin Steriles is an India-based sterile pharmaceuticals company focused on the development, manufacture, and commercialization of injectable and ophthalmic generic products for regulated markets, especially the United States. The company is a subsidiary of Caplin Point Laboratories and operates as a specialized sterile-products arm with capabilities spanning R&D, regulatory filings, manufacturing, and partner-supported commercialization. Its portfolio includes simple and complex injectables, infusion bags, suspensions, emulsions, lyophilized products, and ophthalmic formulations, and it has built a substantial U.S. ANDA pipeline with numerous FDA approvals. Caplin Steriles also supports external partners on a CDMO basis and has front-end U.S. commercial operations through Caplin Steriles USA. The business is centered on commercial-stage generic products rather than novel therapeutics.