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US Food and Drug Administration flags Sun Pharma's Halol plant, warns product approvals may be put on hold

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Sun Pharmaceutical Industries seems to have suffered a setback as the US Food and Drug Administration (FDA) has placed its Halol plant under 'official action indicated'.

Informing about this to the stock exchanges on 29 March, the company said that FDA approvals for products manufactured at its plant in Gujarat's Halol may be put on hold.

The Dilip Shanghvi-led company also faces the risk of getting a warning letter from FDA, which expects the pharma company to take corrective action at the plant.

Although Sun Pharma's dependence on the Halol plant for its exports to the US has come down over the years, supplies to the country still contribute approximately 3 to 4 percent of its consolidated revenues.

In a letter to BSE, Sun Pharma informed that product approvals for US market may get postponed till the plant starts working in line with FDA norms. However, the current orders will be dispatched as per schedule.

The company said that it does not see any major supply disruption due to the new norm and it will work with the regulator to ensure that there will be no shortage of supply to the US.

The letter also mentioned that a re-inspection of the plant is also possible. The FDA conducted inspection of the plant in December. But, in view of the rapid spread of coronavirus, the inspection may be delayed.

 

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