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The United States Food and Drug Administration (USFDA) retains the Official Action Indicated (OAI) status for Goa Plant - I (Finished Dosages Facility) of Indoco Remedies . The facility was inspected by the USFDA in January, the company informed the bourses. “We are in the process of sending our responses to the regulators, as and when the commitments given in response to Form 483 observations are fulfilled. We believe that this OAI status will not impact our current commercial supplies to USA or revenues from this manufacturing facility. However, this may withhold approval of our pending ANDAs from this facility,” said Indoco Remedies. The plant currently supplies against one approved ANDA and has four ANDAs pending for approval. Shares of Indoco Remedies jumped 9.58 per cent at ₹217.40 on the BSE.
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