Date: 5th August 2026
Regulatory Compliance Update
USFDA Inspection Details:
- United States Food and Drug Administration (USFDA) conducted inspection of manufacturing facility
- Facility location: Pashamylaram, Hyderabad (FEI No. 1000623515)
- Inspection period: July 27, 2026 to August 5, 2026
Inspection Outcome:
- Received Form FDA 483 containing five observations
- None of the observations relate to data integrity issues
Company Response Plan:
- Detailed assessment of observations is currently underway
- Preparing comprehensive response including appropriate corrective and preventive actions (CAPAs)
- Response will be submitted to USFDA within stipulated timeline
- Company believes observations are addressable
- Committed to working closely and constructively with USFDA for timely resolution
Quality Commitment:
- Company maintains commitment to highest standards of quality and regulatory compliance
- Dedicated to continuous improvement across operations
- Focus on sustaining robust quality systems that support patient safety and regulatory compliance
Not Specified Sections
Financial Results, Dividend Declaration, KMP/Board Changes, Board Meeting Outcomes, Auditor's Report, Disinvestment/Strategic Actions, Media Release/Investor Communication, and Other Operational/Legal/Strategic Disclosures were not addressed in this disclosure.