Granules India Wraps Up USFDA Inspection at Bonthapally with Single Observation

20 Jun 2025 , 07:00 PM

Granules India Ltd informed the exchanges on Friday that the U.S. FDA has completed its inspection of the company’s API Unit-I at Bonthapally, Telangana, which concluded with just one Form 483 observation.

The five-day inspection ran from June 16 to June 20, 2025. The company said it is preparing a response and will address the observation within the timeline prescribed by the U.S. regulator.

The Bonthapally facility, located near Hyderabad, is a critical site for the company. It houses one of the world’s largest Paracetamol API manufacturing plants. It also produces Metformin and Guaifenesin, both of which are widely used in chronic and respiratory medications.

On the financial front, Granules posted modest growth in revenue for the March quarter. The topline rose 1.8% year-on-year to ₹1,197.5 crore, compared to ₹1,175 crore in the same period last year. Operating profit (EBITDA) slipped 1.4% YoY to ₹252 crore, while EBITDA margins narrowed to 21.1% from 21.8%, indicating some cost pressure. Despite softer margins, the bottom line held up well. Net profit for the quarter increased by 18%, reaching ₹152 crore, supported by strong demand across key therapeutic segments.

Granules India Ltd shares closed at ₹482.80 which is a 0.52% gain on June 20, 2025. In the National Stock Exchange, Granules India Ltd shares have dipped 0.98% dip in the last year, 19.18% in the year-to-date, and 6.47% dip in the last month.

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