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Our API (Active Pharmaceutical Ingredients) program began in 1995 with a simple objective - facilitating the manufacture of complex formulations, products for which complete vertical integration would help the business. We currently make APIs at 9 plants, including locations in Hungary, US and Israel. Technical capability and dedicated sites to make complex API such as anticancers, peptides, sex hormones and controlled substances
are an important feature of our API business. |
Over time, we have been able to take this advantage to international markets, particularly to the US.
Our recent acquisition of Taro brings to the table a strong API business manufactured out of its Haifa Bay,
Israel, site.Taro makes a comprehensive list of API including warfarin, carbamazepine, etodolac & clorazepate.
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Starting with 2 actives in 1995, our API list has since expanded to over 200, and this includes a number of APIs with regulated market approvals such as US and European drug master files (DMFs)
Most of our plants are ISO 14001 and ISO 9002 approved, besides being approved by the respective foreign regulatory authorities. Every year we scale up about 25 APIs, and make a large number of filings based on the technology we develop at our research centre. |
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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.
In November 2008, we acquired Chattem Chemicals, Inc., which is licensed by the DEA to manufacture Schedule 1 to 5 controlled substances. It has a facility spread over 6.5 acres in Chattanooga, Tennessee, where it manufactures a large number of controlled substances.
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Our ability to make high quality, complex APIs and skills in product development and scaleup are expected to power our API strategy going ahead.
Click here for Sun Pharma's API product list.
Click here for Chattem's API product list
Click here for Taro's API product list
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