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CNBC TV1812-12-2025, 17:07

Granules India's GLS Hyderabad unit clears US FDA quality inspection

  • Granules Life Sciences (GLS), a Granules India subsidiary, received an Establishment Inspection Report (EIR) from the US FDA for its Hyderabad facility.
  • The US FDA inspection, conducted from July 28 to August 1, 2025, confirmed the Hyderabad facility's compliance with FDA quality standards.
  • This approval signifies the facility's adherence to regulatory requirements for manufacturing PFI and finished dosages.
  • Granules India's shares increased by 1.64% on December 12 following the news.
  • In the September quarter, Granules India reported a net profit of ₹131 crore and revenue of ₹1,297 crore.

Why It Matters: This ensures Granules India's Hyderabad unit meets US drug quality standards.

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