For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
BUSINESS
GMP Violations at Drug Substance Makers Prompt Series of New Voluntary Recalls of Generics; Stable Supplies Disrupted
A number of generic drug makers have initiated voluntary product recalls due to defects in production control identified by the Pharmaceuticals and Medical Devices Agency (PMDA) through its GMP compliance inspections. As of January 10, Nichi-Iko Pharmaceutical, followed by Teva…
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A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
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The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
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Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…