Sun Pharmaceutical Industries Ltd.
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Our API (Active Pharmaceutical Ingredients) program began in 1995 with a simple objective - facilitating the manufacture of complex formulations, for which, sourcing the API would restrict entry. Over time, we have been able to take the benefits of vertical integration to international markets and our US generic subsidiary, Caraco, has been able to source the active of several key products to its advantage.
Starting with 2 actives in 1995, our API list has since expanded to over 150, and this includes a number of APIs with regulated market approvals such as US and European drug master files (DMFs), filed out of Indian plants that hold international regulatory approval and one plant in Hungary. At our seven API plants, every year we scale up about 20 APIs, and make a large number of filings, the technology for all of which is developed at our research centre. Currently this list addresses customers-both innovator companies and generic companies, in markets across Europe, Latam and the US.
A range of APIs including complex actives like anticancer, steroids, peptides and hormones are manufactured in dedicated areas that follow international norms for systems and processes. Our buyout, in 2005, of ICN Hungary (Alkaloida) has enabled us to enter the controlled substance API manufacturing space, one of the few sites in the world to hold these approvals.
Complex APIs, controlled substances, APIs for the regulated markets - all of these are expected to power our API strategy going ahead.
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