Strides receives USFDA approval for Acetaminophen and Ibuprofen Tablets

Strides Pharma Science Limited has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Acetaminophen and Ibuprofen Tablets, 125 mg /250 mg (OTC), from the United States Food & Drug Administration (USFDA). 

The product is bioequivalent to the reference listed drug (RLD), Advil Dual Action with Acetaminophen, 125 mg /250 mg (OTC), of Haleon US Holdings. 

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 Acetaminophen and Ibuprofen tablets will be manufactured at the company’s 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. 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. 

trides Pharma Science Limited has secured approval from the US Food and Drug Administration (USFDA) for its Acetaminophen and Ibuprofen tablets, specifically in the 125 mg/250 mg over-the-counter (OTC) formulation.¹ ² ³ This approval is a significant milestone for the company, as it expands its portfolio of OTC products in the US market.⁴

The approved product combines two widely used pain-relieving medications, acetaminophen and ibuprofen, into a single tablet. This combination is commonly used to treat various types of pain, including headaches, fever, and muscle aches.

Strides Pharma Global Singapore, a subsidiary of Strides Pharma Science Limited, received the approval. This development is expected to strengthen the company’s presence in the US pharmaceutical market.