Granules India shares will be in focus on Monday (November 2) after the company reported that the US FDA has issued Form 483 to the company’s Hyderabad Unit with 11 observations after concluding a GMP inspection at a Hyderabad facility. This confirms the CNBC-TV18 newsbreak. Earlier on October 19, CNBC-TV18 had reported that the US FDA began an audit of Gagillapur. CNBC-TV18 had reached out to Granules for a comment.
CNBC-TV18 Newsbreak Confirmed
In an exchange filing issued on Saturday, October 31, the company said that the United States Food and Drug Administration (USFDA) concluded a current Good Manufacturing Practice inspection of its finished dosage facility at Gagillapur, Hyderabad. The inspection, as mentioned before, concluded with the issuance of Form 483 with a total of 11 observations.
The said inspection was conducted from October 19 to October 30, 2026.
As per the US drug regulator, an FDA Form 483 is issued to a company when an FDA investigator has observed any violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts.
Observations are conducted when, in the investigator’s assessment, the conditions or practices noted suggest that any food, drug, device, or cosmetic has been adulterated or is being prepared, packaged, or stored in a manner that could lead to adulteration or pose a health risk.
Company’s Reaction
The Telangana-based company said 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.
For its part, the company has claimed that none of the observations was related to data integrity or cross-contamination.
Furthermore, according to Granules, the observations concern the enhancements in investigations, change control, process and equipment qualification, visual-inspection controls and documentation practices.
The company further added that there is no impact on manufacturing or distribution of products from the site. In addition, Granules also added that the company will submit a ‘comprehensive’ response to the US drug agency within 15 days.
Commenting on the inspection, Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, said: “The inspection progressed constructively, and the observations are of a nature that we believe can be fully addressed through our responses and corrective and preventive actions. Quality is the foundation of everything we do at Granules, and we will continue to engage transparently with the agency.”
Ahead Of Q2 Results
The company will be reporting its results for the second quarter or Q2FY27 on November 2. Ahead of that, when we look at its performance in Q1, the pharma company’s Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) for the June quarter 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. Granules India’s net profit for the period increased by 60% year-on-year to ₹180 crore from ₹112.60 crore. Revenue grew 22% to ₹1,476 crore from ₹1,210 crore during Q1 of FY26.
Stock Performance
When we look at the performance of the pharma company’s stock, the shares of the company 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%.
Furthermore, the stock is 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.
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