Granules India announced that its wholly owned subsidiary, Granules Life Sciences Pvt. Ltd., has successfully completed a Good Manufacturing Practices and Prior Approval Inspection by the USFDA at its Hyderabad facility. The audit ended with five procedural observations, none related to data integrity or product safety.
Granules India Limited informed that its subsidiary, Granules Life Sciences Pvt. Ltd. (GLS), Hyderabad, has concluded a comprehensive inspection by the U.S. Food and Drug Administration (USFDA). The inspection, which took place between December 15 and 19, 2025, reviewed the facility’s compliance with Good Manufacturing Practices (GMP) and Prior Approval processes.
The company reported that the audit closed with five observations concerning procedural aspects — none impacting data integrity or product safety, signaling the robustness of its quality systems. Granules India reaffirmed its commitment to corrective actions and stated it will submit a detailed response to the USFDA within the stipulated timeframe.
Granules Life Sciences operates as a key manufacturing arm for Pharmaceutical Formulation Intermediates (PFI) and Finished Dosages, reflecting the company’s integral role in the global supply chain.
Key Highlights / Major Takeaways
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Inspection type: GMP and Prior Approval by USFDA
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Location: GLS Hyderabad facility (FEI: 3030495702)
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Timeline: Conducted from December 15–19, 2025
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Result: Five procedural observations; no data integrity or product safety issues
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Next steps: Company to respond to USFDA promptly
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Business focus: Manufacturer of PFIs and Finished Dosages
Source: NSE Corporate Filings and BSE Announcements