Value-added Services

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Dr. Reddy’s CPS supports you with a full range of chemical and analytical services including life cycle management and portfolio management. Our expertise in intellectual property and regulatory issues helps us consistently deliver the highest quality APIs that meet or exceed regulatory standards. At the same time, our agility enables our customers be the first-to-market by providing offerings ranging from intermediates to end formulations.

 

Analytical Services

  • Method Development and Validation in accordance to ICH guidelines
  • Characterization of impurities
  • Stability studies in accordance to ICH guidelines
  • Solid-state development

 

Lifecycle Management

  • A strong portfolio of more than 170 products for leading therapeutic areas
  • IP assessment as an integral part of product development to facilitate launch of line extensions (combinations, new or reformulation) on product patent expiry
  • Typical to have a non-infringing synthetic process or novel polymorph
  • Portfolio of ANDAs either filed or in the pipeline that offer ready-to-use or easily customizable sourcing solutions for prescription to OTC switches
  • Combination Drug Development: generic API combined with an innovator API in a novel delivery system

 

Portfolio Management

  • 125+ dosage filings in the US, 20+ in Europe and 1400+ in the rest of the world
  • Products on the market in key geographies such as US, UK, Germany, Romania, Bulgaria, India, Russia, Ukraine/CIS, Venezuela
  • Formulation development team that has expertise in customizing existing products to meet innovator trade-dress requirements if needed

 

For more information, please contact us on contactcps@drreddys.com