Granules India shares will be in focus on Monday (November 2) after the company reported that the US FDA issued Form 483 with 11 observations for its Hyderabad facility following a GMP inspection. According to the company's exchange filing issued on Saturday, October 31, the US Food and Drug Administration concluded a current Good Manufacturing Practice inspection of its finished dosage facility at Gagillapur, Hyderabad. The inspection was conducted from October 19 to October 30, 2026, with the FDA issuing Form 483 when investigators observe violations of the Food, Drug and Cosmetic Act.
The Telangana-based company stated that this was the first USFDA inspection of the facility since the Warning Letter of February 26, 2025, which followed an inspection in August-September 2024. According to Granules, none of the observations were related to data integrity or cross-contamination. The company explained that the observations concern enhancements in investigations, change control, process and equipment qualification, visual-inspection controls and documentation practices. Granules has confirmed there is no impact on manufacturing or distribution of products from the site, and the company will submit a 'comprehensive' response to the US drug agency within 15 days.
The company will be reporting its results for the second quarter or Q2FY27 on November 2. In Q1 performance, Granules India's Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) rose by 37.4% YoY to ₹339 crore from ₹246.5 crore. The EBITDA margin expanded by over 300 basis points to 23% from 20.3% YoY. Net profit increased by 60% year-on-year to ₹180 crore from ₹112.60 crore, while revenue grew 22% to ₹1,476 crore from ₹1,210 crore during Q1 of FY26.
The pharma company's shares closed in the green on Friday with minimal gains of 0.29%. In this year's trade so far, the stock price has expanded its value by over 35%. The stock is currently at over 9% below its 52-week high of ₹923.65 and sitting with a cushion of 58.49% above its 52-week low of ₹529.85. The stock has made major gains over the past week and has closed in the green in 7 out of the last 10 trading sessions.
