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Biocon Insulin Plant Gets FDA Form 483s As Aspart Awaits Action

Six Observations Issued By US Agency Following On-Site Pre-Approval Inspection

Executive Summary

Six Form 483 observations of GMP deficiencies have been received from the US FDA by Biocon after the agency inspected the Malaysian manufacturing facility for its insulin aspart biosimilar. However, the Indian firm – which is partnered with Viatris on the product, for which an interchangeability designation is also being sought – insisted that US commercialization plans would not be affected.

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