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Biocon’s Malaysia Insulin Facility Hit With 12 FDA Observations

 
• By Penelope MacRae

The US FDA has slapped Biocon with a dozen observations over three units at its insulin manufacturing facility in Malaysia, but the Indian biotech firm says the problems can be remedied quickly and that US launch plans are on track for its insulin product glargine challenging French drug-maker Sanofi’s multi-billion-dollar Lantus.

Broken eggs
A Dozen Deficiencies Were Observed By The Agency • Source: Shutterstock

The US Food and Drug Administration has served Indian biotech leader Biocon with 12 observations over three units at its Malaysia plant where the firm will produce its insulin glargine, expected to take on Sanofi’s best-selling Lantus drug in the US. But Biocon’s managing director Kiran Mazumdar-Shaw said the FDA observations were “largely procedural” and the problems stemmed from “silly human errors” that can be swiftly rectified. 

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