Apitoria Pharma Pvt Ltd receives 5 observations from USFDA for API facility

The United States Food and Drug Administration (US FDA) inspected Unit-I, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, situated at Borpatla Village, Hatnoor Mandal, Sangareddy District, 502296, Telangana from August 21 to August 29, 2025.

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported. We will respond to the US FDA within the stipulated timelines.

The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1027.70 as compared to the previous close of Rs. 1028.65. The total number of shares traded during the day was 115211 in over 3124 trades.

The stock hit an intraday high of Rs. 1040.00 and intraday low of 1020.55. The net turnover during the day was Rs. 119209551.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 Pharmaceuticals ApitoriaPharma USFDA Form483 APIFacility Unit1 5Observations