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The company, which makes fermentation and semi-synthetic antibiotic drug substances and drug products, said FDA's guidance also fails to provide clarification for adjusted thresholds for impurities in products such as its own
FASEB Journal, 25(3), 907915
The research community has moved decisively toward combination protocols for good reason
The company says that the lots may be contaminated with diluted propylene glycol-based coolant from a machine leakage during the packaging process
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