The US Food and Drug Administration (USFDA) has approved Strides Pharma Global Pte. Limited, a Singapore-based wholly-owned subsidiary of Strides Pharma Science Ltd, an Indian pharmaceutical company, for its generic version of over-the-counter (OTC) painkillers that contain acetaminophen and ibuprofen. The announcement was made on Monday. These tablets will provide customers with a dual-action pain treatment option. They come in dosages of 125 mg and 250 mg.
The recently approved medicine is bioequivalent to Haleon US Holdings LLC’s over-the-counter Advil Dual Action with Acetaminophen, 125 mg/250 mg. Bioequivalence guarantees that the generic medication has the same therapeutic impact as the name-brand medication by having the same potency, dosage form, and mode of administration. With this permission, Strides Pharma can now manufacture and sell these painkillers in the US, increasing its market share in the over-the-counter sector.
The business views this clearance as a calculated step to improve its current line of over-the-counter medications. Strides Pharma hopes to provide customers a potent, two-pronged pain relief remedy by launching the combination of acetaminophen and ibuprofen. It is anticipated that a broad spectrum of people looking for treatment from many kinds of pain, including headaches, muscular pains, and other typical discomforts, will find this medication appealing. The dual-action formulation is a complete pain management solution since it combines the anti-inflammatory actions of Ibuprofen with the pain-relieving qualities of Acetaminophen.
Strides Pharma stressed that superior production standards will be guaranteed since the product will be produced at its flagship facility in KRSG, Bengaluru. This institution is renowned for its cutting-edge infrastructure and strict compliance with regulations.
These tablets’ approval and subsequent release are a component of Strides Pharma’s larger plan to improve its standing in the US market, especially in the rapidly expanding over-the-counter (OTC) sector. The company is committed to broadening its range of products in order to satisfy the various demands of patients and consumers while guaranteeing practical and affordable solutions for the treatment of common medical ailments.
All things considered, Strides Pharma’s USFDA approval represents a significant turning point in its international growth initiatives and underscores the rising demand for generic treatments that offer reasonably priced substitutes for name-brand ones.
SOURCE :
ECONOMIC TIMES
