Strides Pharma Science arm gets USFDA nod for Acetaminophen and Ibuprofen Tablets
Bangalore: Strides Pharma Science Limited has announced that its stepdown 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 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 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 antiinflammatory 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.
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Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donorfunded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York).
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