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Pharmaceutical Manufacturing and Packing Sourcer

The Strongest Link

The pharmaceutical and biotechnology market landscapes are changing rapidly, elevating the risk to the product supply chain. The proliferation of low-cost API and drug manufacturers in the BRICK nations (Brazil, Russia, India, China, Korea) presents a new set of opportunities and challenges. Pressure to perform by shareholders and governmental encouragement to make new drug therapies available to a wider population at a lower cost are spurring manufacturers to look for new and innovative ways to boost business performance. Recent history has seen an unprecedented level of consolidation, as pharmaceutical and biotech giants strive to leverage synergistic product portfolios in exchange for increased development and manufacturing horsepower. However, the trend to utilise low-cost API and excipient suppliers overseas has further complicated supply chain activities within the industry. Couple this with federal and state legislation regulating component and final product traceability, and the recipe for ensuring drug safety quickly becomes complex and risky. High profile transgressions such as the Baxter Heparin adulteration issue have heightened public awareness of the fact that the rules of the supply chain game have changed. In such a charged atmosphere, applying conventional thinking to supply chain integrity will not work in this new global marketplace.

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Bikash Chatterjee is President and Chief Technology Officer of Pharmatech Associates, Inc. He has been involved in the biopharmaceutical, pharmaceutical, medical device and diagnostics industries for more than 25 years. Bikash has guided the successful approval of over a dozen new products in the US and Europe, and is a frequent speaker at industry and regulatory events. He has published, and is a regular editorial contributor to, several internationally recognised industry journals. He holds a BA in Biochemistry and a BS in Chemical Engineering from the University of California at San Diego.
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Bikash Chatterjee
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