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The Factory Floor: Biocon Celebrates Malaysian Insulin Plant Clearance

As MedPharm And Lupin Successfully Complete FDA Inspections

 
• By Akriti Seth

Biocon has reported FDA clearance for its Malaysian insulin facility, while Lupin and Xellia have also received plant approvals. Meanwhile, Alembic has seen mixed fortunes, receiving both Form 483 observations and an EIR.

Biocon_Magnified
Biocon has received an FDA nod for its key insulin plant in Malaysia • Source: Shutterstock

Biocon has announced that its insulin manufacturing facility in Malaysia has received an establishment inspection report from the US Food and Drug Administration, closing out an inspection conducted between 10 February and 21 February this year with ‘voluntary action indicated’ status for the plant.

The facility is a key plant for Biocon as it manufactures the insulin glargine product for which Biocon and partner...

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