Aurobindo Pharma Limited announced that its wholly owned subsidiary, Apitoria Pharma Private Limited, has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Unit-I API manufacturing facility located at Borpatla Village, Hatnoor Mandal, Sangareddy District, Telangana.
Key Highlights
Inspection Details:
The USFDA conducted a for-cause inspection at Apitoria Pharma’s Unit-I facility between August 21 and August 29, 2025. Following the inspection, the agency issued a Form 483 with five observations.
Closure of Warning Letter:
The facility had earlier received a Warning Letter dated January 14, 2022. After reviewing the company’s corrective and preventive actions (CAPA) in response to both the Warning Letter and the Form 483 observations, the USFDA concluded that all cited issues have been adequately addressed. The warning letter is now considered closed.
EIR Classification:
The Unit has been classified as “Voluntary Action Indicated (VAI)”, which means that while some objectionable conditions were found, the USFDA does not plan any further administrative or regulatory action at this time. The inspection is officially closed.
About Aurobindo Pharma
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. It develops, manufactures, and markets a broad portfolio of generic pharmaceuticals, branded specialty drugs, and active pharmaceutical ingredients (APIs) across over 150 countries.
The company operates 31 manufacturing and packaging facilities approved by leading international regulatory agencies such as USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA.
Therapeutic Focus Areas
Aurobindo’s product portfolio covers seven major therapeutic categories:
- Central Nervous System (CNS)
- Anti-Retroviral (ARV)
- Cardiovascular System (CVS)
- Antibiotics
- Gastroenterology
- Anti-Diabetics
- Anti-Allergic
Its innovation and R&D efforts continue to support global healthcare needs with quality and compliance at the core of operations.
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