Strides Pharma US unit gets 4 observations after FDA scan, says no supply impact

Strides Pharma Science Ltd on Wednesday, December 24, said the United States Food and Drug Administration (FDA) has completed a routine current Good Manufacturing Practices (cGMP) inspection at the formulations facility of Strides Pharma Inc (SPI), USA, a step-down wholly-owned subsidiary of the company.

The inspection was conducted at the Chestnut Ridge facility in New York between December 17-23, 2025. At the conclusion of the inspection, the FDA issued a Form 483 with four observations.

The company

said the observations are procedural in nature and are not expected to have any impact on the supply of its commercial products.

The press release stated that the company will submit a comprehensive response to the regulator within the stipulated timeline and expressed confidence in addressing all the observations to FDA's satisfaction.

Strides Pharma Q2 results

Strides Pharma reported a strong financial performance for the second quarter, with net profit rising 82% year-on-year to ₹131.5 crore, compared with ₹72.2 crore in the corresponding period last year.

Revenue for the quarter increased 4.6% year-on-year to ₹1,221 crore. Earnings before interest, tax, depreciation and amortisation (EBITDA) grew 25.4% to ₹232 crore, while the EBITDA margin expanded by over 300 basis points to 19% from 15.8% a year ago.

The company’s gross margin also saw a sharp improvement, expanding by 500 basis points to 57.8% in the quarter, compared with 52.8% in the year-ago period.

Shares of Strides Pharma Science Ltd ended lower on Wednesday, December 24, by 3.59% at ₹936 on the NSE.

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