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 ...
Daiichi Sankyo will close an active pharmaceutical ingredients (API) plant in Hiratsuka, Japan, by September 2017. Opened in 1962, the facility employs 150 people and is one of Daiichi Sankyo’s four ...
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, ...
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators ...
The US Food and Drug Administration (FDA) this week released a warning letter sent to Okayama, Japan-based active pharmaceutical ingredient (API) manufacturer Daito Kasei Kogyo for releasing numerous ...
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