South Korean CDMO consolidates, plants flag in California

by Eric Palmer

fiercepharma.com – South Korean conglomerate SK Holdings jumped decidedly into contract manufacturing a couple of years ago with deals for API plants in Ireland and the U.S. Now, it is rolling those into a group that includes its plant in South Korea in hopes of becoming a key player in the business.

The drugmaker over the weekend said it is merging its SK biotek in Korea and SK biotek in Ireland along with Ampac Fine Chemicals in the U.S. to form SK Pharmteco, the Korea Biomedical Review reports. It has named Aslam Malik, CEO of Ampac, to head the CDMO and established its headquarters in Sacramento, California.

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Water leak fixed with zip ties indicative of Dr. Reddy’s sterile plant failings

by Eric Palmer

fiercepharma.com – When an FDA inspector raised questions about water streaming down some equipment in the fill-and-finish area at Dr. Reddy’s oncology plant in Duvvada, India, a quality control manager repeatedly waved it off as condensation.

When the inspector pointed out it was flowing from a tube that someone had tried to fix with three zip ties and was a problem in a sterile area, the manager finally acquiesced and stopped the filling line.

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