Sun Pharmaceutical Industries Ltd. - Pharmaceuticals, US Generics, API

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API

We make speciality API at large worldclass sites(click for a list) with multi reaction and multi capacity flexibility. In all, the total reaction capacity is over 1220 KL/year.

Our Hungarian plant is part of a recent acquisition, that of the company ICN Hungary, formerly known as Alkaloida. This is one of the few sites worldwide authorized to make controlled substance APIs. The site offers manufacturing capacity of more than 500 KL over a 170 acre site, with dedicated areas for controlled substances. Eight of its actives including several controlled substances are approved for Europe.

Our plants at Panoli and Ahmednagar address the regulated markets while the remaining sites manufacture for India and the developing nations. Our Ahmednagar site holds USFDA, European, OHSAS 18001 ISO 9002 and ISO 14001 approval. Our Panoli site is USFDA, Australian TGA and ISO 9002 approved. Both these plants are equipped with dedicated areas for the manufacture of complex API such as steroids, peptides, anticancer and sex hormones. Dedicated, self-contained plants with separate air handling systems and material flow have been set up to comply with international requirements for the manufacture of these high-value products under a tightly controlled environment. Our intent is to address the international opportunity for these complex products.

The tally for regulated market approvals for APIs at the end of the first quarter of 2007-08 is 43 regulated market approvals, of 91 filings made for DMFs and CEP.

Our site at Kharkhadi, the Phlox Pharma site holds European DMF approval for Cefuroxime Axetil. We have recently added capacity to make a number of higher end Cephalosporins, which are intended for the regulated markets. A manufacturing site to make sterile and non sterile Cephalosporins formulations is expected to begin operations shortly.

All our plants are large, well-designed and comply with international requirements. Infrastructure, processes and systems at our plants support a flexible product mix and quick product changeovers. Validated systems that are constantly upgraded are in place. Well-defined standard operating procedures have been documented and implemented. Our quality norms are stringent - whether it relates to the manufacture of formulations or API. This is the reason why our actives have repeat buyers in the stringent regulated markets of US, Europe and Latam.

We continually add new products to our product list - these new products either address large international markets or help us compete across markets with an interesting formulation. We scale up over 20 API processes including processes for DMFs every year.