Japan is legendary for its focus—many would say obsession—on producing high-quality products. When it comes to sourcing active pharmaceutical ingredients (APIs), Japanese generic drug firms are ...
The FDA slapped Japanese API maker Yuki Gosei Kogyo with a warning letter, citing the Tokyo-based company for failing to report lab testing data on released lots. The warning letter was in response to ...
A Japanese API maker told the FDA that it had a “lack of awareness of the seriousness” of its GMP violations after admitting to the agency that it had manipulated data during its API testing. The ...
Japan has a large, well-developed pharmaceutical market and offers universal health coverage to its citizens. The country has one of the most advanced research and development facilities across the ...
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