USFDA Approval granted for Acetaminophen and Ibuprofen Tablets

This USFDA approval marks a significant step forward for Glenmark, strengthening their foothold in the lucrative American pharmaceutical market

The Health Master

May 1, 2024

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USFDA Drug product Approval — USFDA Approval

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Last Updated on May 11, 2024 by The Health Master

USFDA Approval

Glenmark Pharmaceuticals, a leading Indian pharmaceutical company, has secured a significant victory with the granting final USFDA approval for their Acetaminophen and Ibuprofen Tablets (250 mg/125 mg) from U.S. Food and Drug Administration (USFDA).

This new over-the-counter (OTC) medication is poised to disrupt the pain relief market, targeting a segment with annual sales exceeding $84 million according to Nielsen syndicated data.

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Bioequivalent to a Leading Brand:

The USFDA’s decision comes after a thorough evaluation process, confirming that Glenmark’s tablets are bioequivalent to Advil Dual Action with Acetaminophen Tablets (250 mg/125 mg) from Haleon US Holdings.

This signifies that both medications deliver the same amount of the active ingredients (acetaminophen and ibuprofen) into the bloodstream at a similar rate, ensuring comparable effectiveness in pain relief.

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Expanding Glenmark’s US Presence:

Glenmark Therapeutics Inc., USA, a subsidiary of Glenmark Pharmaceuticals, will be responsible for distributing the new tablets across the U.S.

This USFDA approval marks a significant step forward for Glenmark, strengthening their foothold in the lucrative American pharmaceutical market.

With an existing portfolio of 195 products authorized for distribution in the US and a robust pipeline of 52 ANDAs (Abbreviated New Drug Applications) awaiting USFDA approval, Glenmark is demonstrating a strong commitment to expanding its offerings and catering to diverse healthcare needs.

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Potential Impact on Consumers:

The introduction of Glenmark’s Acetaminophen and Ibuprofen Tablets presents several potential benefits for consumers:

Increased Access to Pain Relief: With a new player entering the market, consumers may have greater access to this combination pain medication, potentially leading to improved availability and potentially more competitive pricing.
Proven Efficacy: The USFDA’s bioequivalence determination assures consumers that the new tablets will be as effective as the existing brand leader in relieving pain.
Broader Treatment Options: The addition of another option empowers patients and healthcare professionals to select the medication that best suits their individual needs and preferences.

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A Promising Future for Glenmark:

Glenmark’s successful USFDA approval for their Acetaminophen and Ibuprofen Tablets signifies a bright future for the company in the U.S. market.

This win not only opens doors to a multi-million dollar market segment but also paves the way for the introduction of their extensive product pipeline, potentially benefiting both the company and American consumers seeking effective and accessible pain relief solutions.

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