USFDA18 Dec 2025, 10:07 am
Aurobindo Pharma Completes US FDA Inspection at Unit-IV of APL Healthcare Subsidiary with 05 Procedural Observations
AI Summary
Aurobindo Pharma Ltd. has completed a US FDA inspection at Unit-IV of its wholly owned subsidiary, APL Healthcare Limited, with the issuance of a 'Form 483' containing 05 procedural observations. The company is committed to maintaining high manufacturing standards and will respond to the US FDA within the stipulated timelines.
Key Highlights
- US FDA inspection completed at Unit-IV of APL Healthcare Limited, a subsidiary of Aurobindo Pharma Ltd.
- 05 procedural observations issued in the Form 483.
- Aurobindo Pharma committed to maintaining high manufacturing standards.
- Company to respond to US FDA within stipulated timelines.
- No significant financial or operational impact on the listed entity.