RAPS

FDA Warns Spanish API Maker for GMP Violations

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Spanish active pharmaceutical ingredient (API) maker Interquim, S.A. for several good manufacturing practices ...
RAPS

FDA Warns Chinese API Maker for Data Integrity Issues

The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered ...
FiercePharma

Japanese API maker Kyowa Hakko Bio admits manipulating testing data

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 ...
FiercePharma

FDA bans products from another Chinese API maker

The FDA has banned products from a Chinese API maker and suggested it get a consultant to direct upgrades after an inspection found serious problems in its manufacturing processes, some of which had ...