Shares of Sun Pharmaceutical Industries Ltd were trading in the red and 3% lower on 12 April after the USFDA issued an ‘official action indicated’ (OAI) on the company’s Dadra facility.

In its regulatory filing, the company said that the US Food and Drug Administration (USFDA) conducted an inspection at its Dadra facility from 4 December to 15 December 2023, following which the US regulator determined the inspection classification status of Dadra facility as Official Action Indicated (OAI).

Earlier, the company announced receiving approval from the Australian Therapeutic Goods Administration for its Winlevi (clascoterone cream 1%), which is used for treating acne Vulgaris in patients aged 12 and above. This approval grants the pharma major exclusive selling rights in Australia from 24 June.

Furthermore, the company has exclusive development and commercialisation rights for Winlevi in the US, New Zealand, Brazil, Australia, Russia, and Mexico from Cassiopeia SpA.

On 6 March, the USFDA gave the company’s Ankleshwar API (Active Pharmaceutical Ingredients) unit the all-clear to manufacture and export.

At 12:33 pm, the shares of Sun Pharmaceutical were trading 3.15% lower at Rs 1,553.10 on NSE.