Aurobindo arm’s peptide API unit in Telangana gets 1 USFDA observation | Hyderabad News


Aurobindo arm's peptide API unit in Telangana gets 1 USFDA observation

Hyderabad: Aurobindo Pharma on Friday informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a routine inspection of its subsidiary, Auro Peptides Ltd’s manufacturing facility in Telangana with one observation.The inspection was conducted from August 17 to 21, 2026, at Auro Peptides Ltd, which manufactures peptide active pharmaceutical ingredients, at Indrakaran village in Kandi mandal of Sangareddy district in Telangana.According to the company, the sole observation related to facility and equipment maintenance and does not involve data integrity or related good manufacturing practice compliance.The company said corrective action was initiated during the inspection and a formal response will be submitted to the US FDA within the stipulated timeline.The company said the outcome reaffirmed its commitment to maintaining quality and compliance standards across its manufacturing facilities, adding that it will inform stock exchanges of further developments as required under applicable regulations.



Source link

Leave a Reply

Your email address will not be published. Required fields are marked *