Shares of Granules India edged 0.29% higher as the market opened on Monday, after the company disclosed that the U.S. FDA had issued a Form 483 to its Hyderabad unit following a GMP inspection.
In the June quarter, Granules reported revenue of ₹1,476 cr, up 22% YoY from ₹1,210 cr, and net profit of ₹180 cr, a 60% surge from ₹112.60 cr in the prior quarter. EBITDA margin widened 300 basis points to 23% from 20.3% in Q1FY26.
The stock, which closed 0.29% higher on Friday, sits 9% below its ₹923.65 52‑week high and 58% above its ₹529.85 low, having gained 35% year‑to‑date. In the last ten sessions, it has finished in the green seven times, underscoring short‑term resilience despite regulatory headlines.
The FDA’s 11 observations cover process control, change control, equipment qualification and documentation practices, but Granules says none touch data integrity or cross‑contamination. Company officials maintain the findings will not affect manufacturing or distribution from the Hyderabad facility and will submit a comprehensive response within 15 days.
Analysts are eyeing the November 2 Q2 FY27 filing for guidance on pricing power and potential regulatory impact. While the company signals continued growth, traders will scrutinize earnings for clues on how the FDA findings might influence future margins and share performance.