USFDA issues Form 483 with one observation to Aurobindo

It's imperative to note that a Form 483 is a document issued by the US FDA when it identifies deviations or lapses during a facility inspection.

The Health Master

September 20, 2023

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Last Updated on December 22, 2024 by The Health Master

Form 483

The well-known pharmaceutical company Aurobindo Pharma recently announced that the US Food and Drug Administration (USFDA) had issued a Form 483 for its Unit IV plant located in Tirupati District, Andhra Pradesh.

This development was reported to the stock exchanges on September 20, 2023.

The inspection, which took place from September 13 to 19, aimed to assess compliance with regulatory standards.

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Form 483: Understanding the Observation

In response to the inspection, the USFDA issued a ‘Form 483‘ containing one procedural observation.

It’s imperative to note that a Form 483 is a document issued by the USFDA when it identifies deviations or lapses during a facility inspection.

Companies are subsequently provided with guidance on implementing corrective measures to rectify the identified issues.

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Significance of a Procedural Observation

According to industry analysts, a procedural observation is considered the least critical among the observations that could be made by the USFDA.

Issues pertaining to quality or data integrity hold greater concern and can potentially lead to more severe actions by the regulator.

In this context, the procedural nature of the observation provides some relief for Aurobindo Pharma and its subsidiary.

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Aurobindo’s Response and Commitment

Aurobindo Pharma has expressed its commitment to addressing the observation promptly. The company has affirmed that it will submit a response to the USFDA within the stipulated timelines.

Furthermore, Aurobindo Pharma has assured its cooperation with the USFDA in order to expedite the closure of the observation.

Analyst Projections and Outlook

Industry analysts have offered insights into the anticipated performance of Aurobindo Pharma.

They project EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) margins to range between 18 to 20 percent for the current fiscal period.

This projection is attributed to shifts in the product mix and a decrease in raw material costs, as indicated in earlier reports.

Additionally, analysts anticipate robust growth in Aurobindo’s US business, driven by the forthcoming launch of g-Revlimid in October 2023.

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Financial Performance Snapshot

Aurobindo Pharma reported a 22.5 percent decline in consolidated net profit, amounting to Rs 540.40 crore, for the April-June quarter. At 11:12 a.m. on September 20, the company’s shares were trading at Rs 892.70, reflecting a marginal decrease of 0.23 percent on the NSE.

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