Strides Pharma Bags USFDA Nod for OTC Acetaminophen-Ibuprofen Combo Tablets

Strides Pharma Science Limited has announced that its wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has obtained approval from the United States Food & Drug Administration (USFDA) for Acetaminophen and Ibuprofen Tablets, 125 mg/250 mg (OTC). The product is bioequivalent to the reference listed drug (RLD), Advil Dual Action with Acetaminophen, 125 mg /250 mg (OTC), from Haleon US Holdings LLC.

"The addition of the Acetaminophen and Ibuprofen Tablets, 125 mg /250 mg (OTC) will significantly enhance our existing portfolio of over-the-counter (OTC) products. 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. This approval underscores our commitment to expanding our product offerings and meeting the diverse needs of our customers," the company stated.

The tablets of Acetaminophen and Ibuprofen will be produced at the company's main plant in KRSG, Bengaluru.

The blend of Acetaminophen and Ibuprofen is employed to alleviate pain from different ailments, including headaches, tooth pain, menstrual discomfort, muscle soreness, or arthritis. Ibuprofen is a nonsteroidal anti-inflammatory medication (NSAID). This combined treatment functions by inhibiting your body's generation of specific natural substances that lead to inflammation. This effect aids in reducing swelling, pain, or fever.