Strides Pharma unit gets USFDA nod for Acetaminophen and Ibuprofen tablets

Strides Pharma on Monday, January 20, said its step-down wholly-owned subsidiary, Strides Pharma Global Pte. Ltd, Singapore, has received approval from the United States Food and Drug Administration (USFDA) for the Acetaminophen and Ibuprofen tablets, 125 mg/250 mg (OTC).

The company said the product is bioequivalent to the reference listed drug, Advil Dual Action with Acetaminophen, 125 mg/250mg over-the-counter (OTC) of Haleon US Holdings LLC.

This addition will significantly enhance the company's existing portfolio of OTC products, it said. "By offering a dual-action pain relief option, we aim to cater to a broader patient base, providing effective and accessible solutions for pain management," Strides Pharma said.

It added that the Acetaminophen and Ibuprofen tablets will be manufactured at its flagship facility in KRSG, Bengaluru.

The combination of Acetaminophen and Ibuprofen is used to relieve pain from various conditions, such as headaches, dental pain, menstrual cramps, muscle aches, or arthritis, the company said. "Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). This combination product works by blocking your body's production of certain natural substances that cause inflammation. This effect helps decrease swelling, pain, or fever," it added.

In the second quarter, Strides Pharma reported a net profit of ₹93 crore, a recovery from a loss of ₹131 crore in the corresponding quarter of the previous year.

The company reported a revenue of ₹1,201 crore for the quarter ended September 30, 2024, a 20.2% increase compared to ₹999.4 crore in the same period last year.

The company reported an improvement in Earnings Before Interest, Taxes, Depreciation, and Amortisation (EBITDA), which stood at ₹235.7 crore, up 54% from ₹153 crore in the corresponding quarter last year.

Strides Pharma shares were trading 2.07% lower at ₹611 apiece at 3 pm on Monday, January 20. The stock has fallen 35.78% in the past six months.

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