As a result of increasing concerns over falsified medicines, reimbursement fraud and theft throughout the pharmaceutical supply chain, by 2019 over 55 countries will have introduced serialisation and track and trace regulations. With varying legislation coming into force across the globe, understanding the requirements of the markets you operate in is of paramount importance.
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Journal of Medicinal Chemistry, 2016, 59, 8577−8592
The many challenges faced by the pharmaceutical industry throughout the supply chain, including fraud and counterfeit medicines, have led to international serialisation requirements in the U.S and Europe. With this in mind, CDMOs have a lot to consider with the new track and trace regulations.
Syn lett, R. Hartmann et al. 20.01.2016
The risk of failure and cost invovled with developing new pharmaceutical products can be significantly reduced by using existing active ingredients in the development process and choosing the right partner for the development of the specific requirements of microtablets is crucial.