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Analysts turn cautious on Cipla as US FDA action delays key US launches

Analysts believe that some of the recent observations from the US FDA are critical in nature and could lead to a potential Official Action Indicated (OAI) classification for the Indore plant

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An employee works at the reception area of Cipla at its headquarters in Mumbai. Photo: Reuters

4 min read Last Updated : Mar 02 2023 | 10:55 PM IST

Analysts have turned cautious on Cipla, as the recently issued form 483 by the US FDA with eight observations to its Pithampur (Indore) plant is expected to delay the launch of the company’s key generic – Advair – in the US. The Indore plant contributes around 5 per cent of Cipla's revenues, as per analysts' estimates.

While the respiratory product, which is used to treat asthma, had cleared the pre-approval inspection of the regulator at the Indore unit; the final approval could be unlikely until the company clears the recent US FDA observations, analysts say.

Prabhudas Lilladher and Motilal Oswal

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