Hyderabad: Aurobindo Pharma on Tuesday informed the bourses that the US Food and Drug Administration has issued one observation for an active pharmaceutical ingredient (API) manufacturing unit of its wholly owned subsidiary Apitoria Pharma Pvt Ltd.
Aurobindo Pharma said the observation is procedural in nature and that the company will respond to the US FDA within the stipulated timeline. It added that it will inform the stock exchanges of any further developments as required under applicable regulations.
The inhaler is expected to be launched in the upcoming quarters in the US market, the company said.
It said the product will be manufactured at its Raleigh facility in North Carolina that is owned by its wholly owned step-down subsidiary Aurolife Pharma LLC. You Can Also Check: Gold Rate in Hyderabad | Silver Rate in Hyderabad | Bank Holidays in Hyderabad | Public Holidays in Hyderabad | Hyderabad AQI | Weather in Hyderabad | Petrol Price in Hyderabad | Diesel Price in Hyderabad | CNG Price in Hyderabad | LPG Price in Hyderabad