PHARMACEUTICALS
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Juzen Chemical ' s facility in Japan
‣ in the API manufacturing industry . Currently , 101 API manufacturers are members of the JBPMA . In the 1980s , several global blockbuster drugs were developed and launched by Japanese pharmaceutical firms and they began to outsource the manufacturing to third parties because of growing global demand for APIs . To meet these new demands , API manufacturers have made capital investments in new facilities and expanded GMP production capabilities . Japanese API manufacturers also grew with the success of blockbuster drugs . In the 1990s , the outsourcing of pharmaceutical chemicals expanded to more nations worldwide . Both types of businesses , pharmaceutical intermediates by specific technology and exclusive API synthesis using GMP , progressed . Major Japanese chemical companies , such as Mitsubishi Chemical , Sumitomo Chemical and AGC , have entered the market through the application of their chemical technology and production capabilities . The expansion of API sales outside Japan provided the US FDA and the European Medicines Agency ( EMA ) the opportunity to inspect Japanese API manufacturers . Since the 2000s , many API manufacturers have obtained approval from the US FDA and other authorities . In 2004 , the Japanese government established the Pharmaceuticals & Medical Devices Agency ( PMDA ) with the aim of integrating the policies for pharmaceutical regulation in Japan . The PMDA has been a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme for GMP cooperation between the regulatory authorities and pharmaceutical industry since 2014 . The three major regulatory agencies ( FDA , EMA and PMDA ) are working together to harmonise GMP worldwide . In recent years , support services for drug development have become another important business sector in the pharmaceutical industry . This concept has been implemented in the context of CDMOs , and the number of global CDMOs has been rising since the 2010s , due to the historical accumulation of technology and abundant opportunities for new drug projects . 6
Technology advances
Japan has a strong tradition of and aptitude for chemistry in academia , with seven Nobel laureates in chemistry . In the 1980s , common chiral intermediates for blockbuster pharmaceuticals , such as the novel carbapenems , cholesterol-lowering drugs , and HIV drugs , became the targets of pharmaceutical intermediate businesses .
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30 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981