Gland Pharma's Hyderabad Facility Receives Establishment Inspection Report From USFDA
Gland Pharma Ltd. received the establishment inspection report from US FDA, confirming that the good manufacturing practices inspection has been closed.
US FDA conducted the inspection at the company's Pashamylaram facility in Hydrabad from July 25, 2025, to Aug. 2, 2024, according to an exchange filing on Saturday.
In August 2024, the US FDA concluded the inspection with three observations. "The observations issued are neither repeated observations nor related to data integrity," said the company.
Gland Pharma Q2 Performance
Gland Pharma's profit dipped to Rs 163.53 crore, representing a 16% fall, for the quarter ended Sept. 30, 2024, of the fiscal 2025 as compared to Rs 194.08 crore for the same period last year.
The pharma major's revenue rose by 2.4% to Rs 1,405.83 crore for the second quarter as against Rs 1,373.42 crore for the year ago period.
The company's earnings before interest, tax, depreciation and amortisation slipped to Rs 297.06 crore, down 8%, for the July-September quarter of the current fiscal 2025 as against Rs 324.08 crore for the same quarter in the previous financial year 2024.
Margins narrowed at 21.1% for the three months ended Sept. 30, 2024, as against 23.6% for the same quarter last year.
Shares of Gland Pharma closed 0.20% higher at Rs 1,679.20 apiece on the National Stock Exchange, compared to a 0.47% fall in the benchmark Nifty. The share price has fallen 13.09% in the last 12 months.
Out of 16 analysts tracking the company, eight maintain a 'buy' rating on the stock, one recommends 'hold,' and seven suggest 'sell,' according to Bloomberg data. The average of 12-month analysts' price targets implies a potential upside of 16.1%.
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