Japan’s pharmaceutical industry is undergoing a period of transformation, and the contract development and manufacturing organization (CDMO) of large molecule active pharmaceutical ingredients (APIs) ...
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 ...
For the second time in recent weeks, the FDA has slapped a Japanese API maker with a warning letter, this time predominantly for data integrity problems at Sekisui Medical. According to the warning, ...
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