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Motilal Oswal Report
We analysed the form 483 issued to Ipca Laboratories Ltd. at Piparia formulation site by U.S. Food and Drug Administration.
U.S. FDA inspected the Piparia site of Ipca Labs between April 18th and 26th and issued form 483 with three observations.
The observations are related to out-of-specification, out-of-trends, documentation of investigations/corrective and preventive action and responsibilities/authority toward quality unit operations.
We believe additional efforts would be necessary to address these regulatory concerns.
Since most of the abbreviated new drug applications held by Ipca Labs are linked to its own active pharma ingredient site at Ratlam, which is currently under import alert, it would be crucial to address the U.S. FDA compliance issues at Ratlam to resume business in the U.S.
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