Ipca Labs - Long Road Ahead For U.S. FDA Compliance: Motilal Oswal

BQ Prime’s special research section collates quality and in-depth equity and economy research reports from across India’s top brokerages, asset managers and research agencies. These reports offer BQ Prime’s subscribers an opportunity to expand their understanding of companies, sectors and the economy. .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..Click on the attachment to read the full report:.Cipla Q4 Results Review - FDA Uncertainty To Weigh On Earnings: Dolat Capital.DISCLAIMERThis report is authored by an external party. BQ Prime does not vouch for the accuracy of its contents nor is responsible for them in any way. The contents of this section do not constitute investment advice. For that you must always consult an expert based on your individual needs. The views expressed in the report are that of the author entity and do not represent the views of BQ Prime..Users have no license to copy, modify, or distribute the content without permission of the Original Owner.

Ipca Labs - Long Road Ahead For U.S. FDA Compliance: Motilal Oswal

Multiple milestones to be crossed for revival of U.S. generics business.

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