USFDA approval granted for Levetiracetam Oral Solution: Strides

The recent approval from the USFDA for Levetiracetam Oral Solution is a noteworthy achievement for Strides Pharma.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

USFDA approval

In a groundbreaking announcement, Strides Pharma Science revealed that its subsidiary, Strides Pharma Global Pte., Singapore, has received USFDA approval from the United States Food & Drug Administration (USFDA) for Levetiracetam Oral Solution USP, 100 mg/mL.

This approval marks a significant stride in the pharmaceutical landscape, and here’s everything you need to know about this development.

Unveiling Strides Pharma Global, Singapore

Strides Pharma Global Pte., Singapore, serves as a crucial step-down wholly owned subsidiary of Strides Pharma Science.

Operating in the vibrant pharmaceutical industry, this subsidiary plays a pivotal role in the company’s global presence and strategic initiatives.

Nod from the USFDA: Levetiracetam Oral Solution

The recent approval from the USFDA for Levetiracetam Oral Solution is a noteworthy achievement for Strides Pharma.

This solution, at 100 mg/mL, demonstrates both bioequivalence and therapeutic equivalence to the Reference Listed Drug (RLD), Keppra Oral Solution, 100 mg/mL, by UCB, Inc. Primarily used in the treatment of seizures, this product addresses a critical medical need.

Bengaluru Manufacturing Facility:

The approved Levetiracetam Oral Solution will be manufactured at Strides Pharma Science’s facility in Bengaluru.

This facility, known for its state-of-the-art infrastructure and adherence to stringent quality standards, further solidifies the company’s commitment to delivering high-quality pharmaceuticals.

260 Cumulative ANDA Filings

With a remarkable track record, Strides Pharma Science has accumulated 260 cumulative ANDA filings with the USFDA.

Notably, over 230 ANDAs have received approval, showcasing the company’s dedication to meeting regulatory standards and bringing innovative products to market.

Implications for Strides Pharma Science

The USFDA approval for Levetiracetam Oral Solution signifies more than just a regulatory milestone.

It positions Strides Pharma Science as a key player in the pharmaceutical arena, with potential implications for market share, partnerships, and future developments.

Navigating the Global Pharmaceutical Landscape

In the broader context of the pharmaceutical industry, Strides Pharma Science stands out for its commitment to excellence.

A comparative analysis with other pharmaceutical giants highlights the company’s unique strengths and contributions to global healthcare.

Future Prospects for Levetiracetam Oral Solution

As the pharmaceutical landscape evolves, so do the prospects for Levetiracetam Oral Solution.

Anticipated developments and expansions, coupled with insights into market trends, provide a glimpse into the future trajectory of this groundbreaking pharmaceutical.

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.

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