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FDA publicly shames Chinese drugmaker for tailor-making inspection documents The FDA doesn’t always announce the warning letters it slaps on drugmakers, much less send out a missive from the commissioner himself. But apparently, the agency considers one set of violations serious enough to publicly call out a Chinese over-the-counter d.. 2019-08-28 Chinese CDMO GenScript takes steps to be player in China's gene and cell therapy market With Western drugmakers taking new-generation meds to China, GenScript Biotech is looking to be a key player in China’s CDMO market for biologics and cell and gene-based treatments. The Chinese company this week formally premiered a clinical supply manufactur.. 2019-08-06 FDA promises 'elevated' new drug approvals, but warns of potential pitfalls: report The FDA has approved 14 new drugs so far this year, lagging behind the 20 approvals it had charted by this time last year. Is it a sign that the FDA is becoming more cautious in the wake of Scott Gottlieb’s departure? After all, it was under his tutelage that.. 2019-07-18 The review of Senova at the CPhI exhibition in Shanghai in 2019 2019 Shanghai CPhI exhibition had achieved successful results on June 20. Wonderful reviewSenova,a leading supplier for advanced intermediates in Generics field.During the exhibition, hundreds of customer representatives from home and abroad welcomed t.. 2019-07-10 in-PHARMA JAPAN 2019 2019-07-05 The acquisition of FDA EIR certificate Congratulations to our cooperative factory for obtaining the usFDA EIR with the support of the SENOVA’s registration team. As for us SENOVA , We are really proud of it.The acquisition of FDA EIR certificate means that the factory has risen to a new level o.. 2019-06-28
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