Aurobindo Pharma Limited has announced the conclusion of a US FDA inspection at its Unit-VI, an API manufacturing facility operated by its wholly-owned subsidiary, Apitoria Pharma Private Limited. The inspection, which took place from August 24 to August 28, 2026, resulted in three procedural observations. The company is committed to addressing these observations within the stipulated timeline and maintaining robust quality standards across its facilities.
US FDA Inspection at Apitoria Pharma Unit-VI Concludes
Aurobindo Pharma Limited has informed the stock exchanges that the United States Food and Drug Administration (US FDA) has completed an inspection of Unit-VI. This facility is an Active Pharmaceutical Ingredient (API) manufacturing unit operated by Apitoria Pharma Private Limited, a wholly-owned subsidiary of Aurobindo Pharma. The inspection was conducted at the facility located in E-Bonangi Village, Parawada Mandal, Anakapalli District, Andhra Pradesh.
Inspection Period and Findings
The US FDA inspection took place from August 24 to August 28, 2026. Following the inspection, the US FDA has issued three observations. The company has characterized these observations as procedural in nature and has affirmed its commitment to providing a comprehensive response to the US FDA within the required timeframe.
Commitment to Quality Standards
Aurobindo Pharma reiterated its dedication to upholding stringent quality and compliance standards across all its manufacturing operations. The company assured stakeholders that it will continue to keep the stock exchanges updated on any further significant developments pertaining to this matter, in accordance with applicable regulations.
Source: BSE
