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 ...
The FDA has suggested an Indian API maker hire a consultant that understands FDA regulations after finding the company didn’t have a grasp of some basic requirements, including how to make sure the ...
The contract research and manufacturing firm Albany Molecular Research Inc. has acquired Gadea Pharmaceutical, a Spanish maker of active pharmaceutical ingredients (APIs) and finished drugs, for $174 ...
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