Major Current Challenges of Excipient Industry


By: Kriti Vatsa -- Senior Reasearch Analyst

27 March, 2015

Major Current Challenges of Excipient Industry

Abstract / Business Case Globally, the growth of parenteral excipient market especially suspension agents and preservatives are driven by increased demand for parenteral drugs from biopharmaceutical industry, which is growing at CAGR of 8-10% in US and Europe. The industry needs suppliers who can manufacture high purity cGMP parenteral excipients having good technical expertise and meeting customers? and regulatory authorities? specification. In the current scenario, there are few qualified suppliers who can meet the demand of the pharmaceutical company. This white paper seeks to understand the market scenario of parenteral excipients. As regulations such as FDASIA (Food and Drug Administration Safety and Innovation Act) and DSCSA (Drug Supply Chain Security Act) along with EU Falsified Medicines Directive have come up in the market, suppliers are mandated to manufacture excipients of high quality. In addition to it, market players are also looking to understand the impact on ExciPact certification and other new regulations such as NSF/IPEC/ANSI-363 on the market. The impact of these regulations is analyzed as well.


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