USFDA approval granted for Generic Gabapentin Tablets

In the highly regulated pharmaceutical industry, obtaining USFDA approval is a hallmark of credibility and quality.

USFDA Drug product Approval
USFDA Approval

Last Updated on February 3, 2024 by The Health Master

USFDA approval

The pharmaceutical landscape is witnessing a groundbreaking development as Zydus Lifesciences receives final USFDA approval from the United States Food and Drug Administration (USFDA) for the manufacturing and marketing of Gabapentin Tablets (Once-Daily), in 300 mg and 600 mg variants (USRLD: Gralise Tablets).

Zydus Lifesciences stands proud as the first company to secure final USFDA approval for these generic Gabapentin Tablets in the United States.

Let’s delve into the significance of this achievement and its implications for both the company and the pharmaceutical market.

Significance of USFDA Approval

In the highly regulated pharmaceutical industry, obtaining USFDA approval is a hallmark of credibility and quality.

Zydus Lifesciences‘ accomplishment in receiving the final nod from the USFDA reflects not only the company’s commitment to excellence but also underscores the rigorous standards met by their manufacturing processes.

This achievement places Zydus Lifesciences in an elite league of pharmaceutical companies with the ability to bring vital medications to the market.

Gabapentin Tablets (Once-Daily)

Gabapentin, the key component of the approved tablets, plays a crucial role in managing Postherpetic Neuralgia (PHN).

Exploring the uses and benefits of Gabapentin sheds light on its significance in the pharmaceutical landscape, particularly in addressing specific medical conditions.

The focus on PHN management emphasizes the targeted approach of this medication.

Manufacturing Facility at Moraiya, Ahmedabad

Zydus Lifesciences’ formulation manufacturing facility at Moraiya, Ahmedabad, takes center stage in ensuring the production of high-quality pharmaceuticals.

Local manufacturing has become increasingly important in the pharmaceutical sector, contributing not only to economic growth but also ensuring a stable supply chain, especially in times of global uncertainty.

Market Impact and Potential

The USFDA approval of Gabapentin Tablets (Once-Daily) marks a strategic move for Zydus Lifesciences, opening new avenues in the competitive pharmaceutical market.

Analyzing the market potential and the expected impact on the company’s market share provides insights into the future trajectory of Zydus Lifesciences.

Annual Sales and Market Statistics

According to the IQVIA Nov. 2023 report, Gabapentin Tablets (Once-Daily), in 300 mg and 600 mg variants, recorded annual sales of $85 million in the United States.

This statistic not only reflects the market demand for the medication but also positions Zydus Lifesciences as a key player in catering to this demand.

Launch Strategy in the US

With the final USFDA approval secured, Zydus Lifesciences plans an immediate launch of Gabapentin Tablets (Once-Daily) in the US market.

Understanding the launch strategy, marketing initiatives, and distribution plans provides a glimpse into how the company aims to capture and serve the market efficiently.

Future Prospects and Innovations

Zydus Lifesciences’ role in the pharmaceutical industry extends beyond this significant USFDA approval.

Exploring potential future developments and innovations sheds light on the company’s vision and its contribution to advancements in healthcare.

As a pioneer in the field, Zydus Lifesciences continues to shape the future of pharmaceuticals.

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.


  1. Is Gabapentin only used for Postherpetic Neuralgia (PHN)?
    • Gabapentin is primarily indicated for the management of Postherpetic Neuralgia, but it may have other medical uses as prescribed by healthcare professionals.
  2. How soon will Gabapentin Tablets (Once-Daily) be available in the US market?
    • Zydus Lifesciences plans an immediate launch of the product following the USFDA approval.
  3. What distinguishes Zydus Lifesciences from other pharmaceutical companies?
    • Zydus Lifesciences has a remarkable track record with numerous approvals and a commitment to innovation, setting it apart in the industry.
  4. Can I expect any variations in the generic Gabapentin Tablets compared to the branded version?
    • Generic medications, including Gabapentin Tablets, maintain the same active ingredients and efficacy as their branded counterparts.
  5. Where can I get more information about Zydus Lifesciences and its product portfolio?
    • For more information, you can visit the official website of Zydus Lifesciences or contact their customer support.

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