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Generics - Research

Process Research
Lupin is well known for its research & manufacturing capabilities and for developing and producing cost-effective and reliable APIs. The Company has built strong capabilities for developing cost-effective, non-infringing, safe and eco-friendly technologies for the synthesis of these intermediates and APIs. The Company’s Process Research capabilities have helped build a robust vertically integrated model for our global generics business. The Company has also expanded its capacity by integrating and upgrading the Dabhasha API facility (formerly Novodigm) to meet demand for Advanced Markets.

In FY 2011, the Company filed 7 US DMF filings taking the cumulative total to 111 DMF filings, and 127 EDMFs/COSs, with several unique and complex APIs.
     
   

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Pharmaceutical Research
The last few years have been landmark years for Lupin in the Pharmaceutical Research domain. In FY 2011, Lupin’s Pharmaceutical Research Group filed 21 ANDAs with the US FDA and 8 European Union applications. The cumulative number of ANDA filings with the US FDA now stands at 148, with 48 approvals received to date. The total cumulative filings within the European Union stands at 91, with 44 total approvals received so far. Furthermore, the cumulative first-to-files now stand at 20.
     
   

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FY2011 saw the addition of development capabilities in new therapeutic areas such as Ophthalmics, Pulmonary pMDIs and DPIs and Dermatology. In order to support business and meet demand in emerging and fast growth markets like India, CIS and Rest of the World, the Company also set up a new state-of-the-art Pharmaceutical R&D center in Aurangabad. The centre commenced full scale operations in September, 2010.

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