Cipla - Pithampur Facility Form 483 Observations, Expect Official Action Indicated Status: Systematix

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. .Systematix Research Report.The U.S. Food and Drug Administration inspected Cipla Ltd.’s Pithampur, Indore facility from February 06 to 17th Feb, 2023. The company had received eight observations for which we have received the Form 483. We hosted a call with Dr. Gurudatta, a regulatory consultant to share his views on the Form 483. The key takeaways being –An official action indicated status / warning letter is the likely outcome which should impact future approvals from the manufacturing facility. OAI status / warning letter is expected as the observations pertain to lack of compliance on procedures for sterility assurance, inadequate investigation on customer complaints and some observations raises suspicion on data integrity (although not established).gAdvair is potentially a key approval that is pending from this facility. We expect the approval to be delayed by at least a year. However, despite the delay, we would still expect the opportunity to remain meaningful and relevant. There are potentially other respiratory assets also filed from this facility. Site transfer of products may not be an option as the process may take longer than it may take to resolve the compliance issues. We are also not sure if Cipla has an alternative manufacturing facility that has capability to manufacture dry-powder inhaler devices. Remediation activity may take at least one year. One of the key observations in the form 483 pertained to customer complaints on products shipped from the Pithampur facility, and failure to conduct investigation and take timely action on Field alert reports. The quantum of customer complaints is disproportionately high. Resolution of the above observation will define the critical path.An import alert is unlikely as data integrity issues have not been established..Click on the attachment to read the full report:.More Research Reports On Cipla.Regulatory Risks On The Rise: Motilal OswalRegulatory Set Back; U.S. Scale Up Gets Delayed: Prabhudas Lilladher.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.

Cipla - Pithampur Facility Form 483 Observations, Expect Official Action Indicated Status: Systematix

The company had received eight observations for which we have received the Form 483.

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