USFDA classifies Lupin’s Somerset facility as ‘Official Action Indicated’

Lupin’s subsidiary — Novel Laboratories’ Somerset facility has been cautioned by the United States Food and Drug Administration (USFDA) that it may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed.

The US Food and Drug Administration (USFDA) had conducted inspection at Somerset (New Jersey) facility in December 2018, and classified it as Official Action Indicated (OAI). ‘Official Action Indicated’, means approvals of pending applications or supplements from this site maybe withheld.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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