Industry

USFDA Approval granted for Dolutegravir Tablets

Out of these filings, an impressive 230+ ANDAs have received the coveted USFDA approval, solidifying Strides' reputation as a trusted pharmaceutical provider.

The Health Master

September 18, 2023

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Last Updated on October 15, 2024 by The Health Master

USFDA Approval

In a significant stride towards global healthcare, Strides Pharma Science has proudly announced that its subsidiary, Strides Pharma Global Pte., based in Singapore, has received tentative USFDA approval from the United States Food & Drug Administration (USFDA) for Dolutegravir 50mg tablets.

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This groundbreaking development marks a crucial milestone in the quest for accessible and high-quality pharmaceuticals.

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A Game-Changing Equivalency

The Dolutegravir 50mg tablet stands as a beacon of hope, being both bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tivicay Tablets, from the esteemed ViiV Healthcare Company.

This endorsement further solidifies Strides‘ commitment to delivering pharmaceuticals of uncompromising quality.

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Empowering Strides: The PEPFAR Pathway

This achievement amplifies Strides‘ commendable track record under the PEPFAR pathway, bringing the total count of approved products to an impressive 13.

The PEPFAR tentative USFDA approval is more than just a regulatory stamp; it opens doors for Strides Pharma Global to partake in global donor-funded programs.

This initiative ensures the wider accessibility of this life-saving medicine across 126 countries, reaffirming Strides’ global impact.

Market Potential: A Glimpse into the Future

The Dolutegravir 50mg tablet boasts a substantial market opportunity in the United States, with a valuation estimated at a staggering $1,345 million, according to IQVIA.

This projection underlines the pivotal role this breakthrough pharmaceutical is poised to play in the healthcare landscape.

Manufacturing Milestone

The manufacturing of these groundbreaking tablets will take place at Strides‘ state-of-the-art facility in Bengaluru, a testament to the company’s commitment to quality and accessibility.

It’s here that the vision of a healthier future takes tangible form.

A Gaze into the Future: Full USFDA Approval Beckons

The journey doesn’t end with tentative USFDA approval. Strides Pharma Global anticipates a seamless transition to full USFDA approval upon the expiration of constraining patents.

This marks the next chapter in the saga of accessible healthcare.

Empowering Communities: A $35 Million Commitment

As of the full year 2022, the estimated value of donor procurement for Dolutegravir 50mg tablets stands at an impressive $35 million.

This figure stands as a testament to the profound impact this pharmaceutical will have on communities around the world.

A Legacy of Excellence

With a remarkable 260 cumulative ANDA filings (including the recent acquisition from Endo at Chestnut Ridge) with the USFDA, Strides Pharma Global has consistently demonstrated its commitment to excellence.

Out of these filings, an impressive 230+ ANDAs have received the coveted USFDA approval, solidifying Strides‘ reputation as a trusted pharmaceutical provider.

Charting a Path Forward

Looking ahead, Strides Pharma Global has set an ambitious target: the launch of 60 new products over the next three years in the United States.

This ambitious goal underscores the company’s dedication to advancing healthcare accessibility and quality on a global scale.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.