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Sun Pharma's product approvals at risk as USFDA labels Halol plant as OAI

Earlier in December, the plant had been issued Form 483 by USFDA with eight observations

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For now, analysts feel not many new drug filings can be expected from Halol in near term even as future drug approvals from the plant becomes crucial

Vinay Umarji Ahmedabad

2 min read Last Updated : Mar 29 2020 | 8:33 PM IST

Sun Pharmaceuticals Industries Ltd (Sun Pharma) on Sunday said that its Halol plant in Gujarat has been classified as 'Official Action Indicated' (OAI) by the United States Food and Drugs Administration (USFDA) after a December 2019 inspection.

OAI means that pending product approval from the facility could be withheld by the regulator. Earlier in December, the plant had been issued Form 483 by USFDA with eight observations. This has escalated into an OAI classification.

"The OAI classification implies interalia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations

Topics : Sun Pharma USFDA

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