Aurobindo's subsidiary AuroPeptides clears USFDA inspection with minor observation

By: IPP Bureau

Last updated : August 21, 2026 5:29 pm



The company said corrective action was already initiated during the course of the inspection itself, and a formal response will be submitted to the US regulator within the stipulated timeline


Aurobindo Pharma Limited has informed that the US Food and Drug Administration has completed a routine inspection at AuroPeptides Ltd, a subsidiary and manufacturer of Peptide APIs, with the facility receiving only one observation. 

The inspection was conducted at AuroPeptides' facility located in Indrakaran Village, Kandi Mandal, Sangareddy District, Telangana, from August 17 to 21, 2026.

According to the company, the sole observation issued related to facility and equipment maintenance and did not pertain to data integrity or related Good Manufacturing Practice (GMP) compliance concerns. 

Aurobindo said corrective action was already initiated during the course of the inspection itself, and a formal response will be submitted to the US regulator within the stipulated timeline.

The company characterized the outcome as reaffirming its continued commitment to maintaining robust quality and compliance standards across its manufacturing network, and said it would keep the exchanges updated on any further developments as required under applicable regulations. 

The disclosure to was made to National Stock Exchange and BSE Limited under Regulation 30 of SEBI's Listing Obligations and Disclosure Requirements.

Aurobindo pharma USFDA

First Published : August 21, 2026 12:00 am