API Services and Intermediates

CPS provides API services covering the complete scope of pharmaceutical product development and commercial life cycle.

Contract manufacture is carried out from Clinical to Commercial manufacture, Life Cycle management options are provided, for example where we have used our product portfolio to enable early launch of combination therapies. In the later stages of the product life cycle, we can provide many options for customers to rationalise their API and finished dosage portfolios.

Contract manufacture

• Second largest API supplier globally with 14000+ MT of API manufactured in the last three years
• 8 FDA inspected, cGMP compliant, ISO certifed API facilities
• Sourcing 850+ raw materials including 265+ KSMs from a global network of strategic suppliers
• 350+ process development and engineering personnel skilled at technology absorption and transfer to manufacturing sites
• 100+ audits from regulatory agencies and innovators every year

Lifecycle management

• Portfolio of 147 USDMFs* (product Listing) for leading therapeutic areas and pipeline of over 20 products at any point of time
• IP Asssessment 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+ Europe and 1400+ in the rest of the world (product Listing)
• Products on the market in the key geographies of US, 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
• Big Pharma looking to rationalize portfolio of finished dosages and hence outsource manufacture of mature products, have access to a substantial ready-for-market basket