Aurobindo Pharma announced the conclusion of the United States Food and Drug Administration (US FDA) inspection at its Unit-VII, an oral solid dosage manufacturing facility in Jedcherla, Telangana. The inspection ran from January 28 to February 10, 2026. At the close of the review, the company received a ‘Form 483’ citing a total of 9 observations, all of which were procedural in nature. The company confirmed there is no impact on financials or operations and committed to timely responses.
US FDA Inspection Concluded at Manufacturing Unit
Aurobindo Pharma Limited has formally informed the stock exchanges regarding the conclusion of the inspection conducted by the U.S. Food and Drug Administration (US FDA). The inspection focused on the company’s Unit-VII, which is dedicated to oral solid dosage manufacturing.
The facility is strategically located at the Special Economic Zone (Pharma), TSIIC, Green Industrial Park, Polepally Village, Jedcherla Mandal, Telangana. The inspection period spanned from January 28 to February 10, 2026.
Key Outcome: Form 483 Issued
As a result of the inspection, the US FDA issued a ‘Form 483’ to Aurobindo Pharma. This form detailed a total of 9 observations made during the review process. Management has characterized all of these observations as being strictly procedural in nature.
The Company Secretary confirmed that Aurobindo Pharma is dedicated to maintaining the highest quality manufacturing standards globally. They further affirmed the commitment to submitting a formal response to the US FDA regarding the noted observations within the stipulated regulatory timelines.
Operational and Financial Impact
A critical takeaway from the disclosure is the assessment of business continuity. The management explicitly stated that there is no impact on the Company’s financials or operations as a result of the findings from this specific US FDA action.
The company confirmed that it will continue to keep the stock exchanges informed should any further substantive information related to this matter arise in the future.
Source: BSE
