Zydus Receives USFDA Approval for Indomethacin Suppository with CGT Designation

Today the D-street had a cautious start as both Sensex and Nifty traded marginally lower by 0.04% each. However, as the day unfolded, the market sentiment worsened, and the indices closed on a lower note with Sensex declining by 0.82% and Nifty falling by 0.74%.

Navigating its way through the dampened market, the shares of Zydus Lifesciences Limited surged 1.97%. The company’s current market capitalization is Rs 64,831.68 crore. 

Zydus Lifesciences Limited has achieved a significant milestone with the final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Indomethacin suppositories, 50mg. This product represents the generic version of the Reference Listed Drug (RLD) Indocin suppositories. 

The USFDA has granted Zydus a Competitive Generic Therapy (CGT) designation for its Indomethacin suppositories, recognizing the product’s potential to offer enhanced benefits to patients. Moreover, Zydus has been awarded a 180-day CGT exclusivity to exclusively market this product, providing a unique advantage in the market.

This approval is a testament to Zydus’ commitment to delivering high-quality and effective pharmaceutical solutions to patients. It opens up new opportunities for the company in the US market and reinforces its position as a leading player in the global pharmaceutical industry. Zydus’ Indomethacin suppositories are poised to contribute significantly to the healthcare landscape, providing patients with a cost-effective and reliable treatment option.

“We are happy to leverage the CGT approval pathway of the USFDA to provide patients with expanded access to a product with limited competition,” said Sharvil Patel, Managing Director, Zydus Lifesciences Limited. 

He further added, “The achievements of our team who have worked on the development, filing and manufacturing of Indomethacin suppositories reflects our ongoing commitment to bring complex generic products accessible to patients who need them the most.”

Company profile 

In 1995, the Zydus group underwent restructuring, leading to the establishment of Cadila Healthcare within its umbrella. Starting with a modest turnover of Rs. 250 crores in 1995, the group experienced remarkable financial growth, achieving a turnover of over Rs. 14,253 crores in FY20.

Adhering to its brand promise of dedicating itself to life in all aspects, Zydus remains committed to innovation and unwaveringly focuses on addressing unmet healthcare needs. Moreover, the company rededicates itself to its mission of fostering healthier and happier communities worldwide.

The stock has witnessed significant buying activity as it has surged more than 84% in the last 1 year.  

Keep a close eye on this trending pharmaceutical stock.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet, and is subject to changes. Please consult an expert before making related decisions.