Why source drug substances from China?
Large markets, economies of scale and cheaper labor;An industrial ecosystem supplying raw materials and equipment;Developed infrastructure and industry friendly policies;About 5,000 manufacturers;
Thousands of chemists and students across China looking for novel synthesis routes for generic drug substances and intermediates.
read all at
http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/Events/DSP_AfterHeparinAndre.pdf
The desire for a dramatic increase in process understanding over
the past eight years has left industry leaders and Global Health
Agencies searching for a more relevant model for developing process and
drug substance understanding. Most recently, the Internationa l Conference on
Harmonization (ICH) has been drafting the ICH guideline q11 on the development and manufacture of drug substances, which takes a considerable step forward, offering sponsors greater flexibility in the definition and selection of Regulatory Starting Materials (RSM).
http://www.triphasepharmasolutions.com/Regulatory%20API%20Starting%20Materials%20Article.pdf
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| The Japanese Ministry of Health, Labour and Welfare (MHLW) has cleared Roche’s Avastin (bevacizumab) as a combination therapy and monotherapy to treat the aggressive form of brain cancer glioblastoma…
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