The Zydus Group has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA).
The Zydus Group, driven by its overarching goal to empower individuals to lead healthier and more enriched lives, is a pioneering global life sciences company. It is involved in the exploration, development, production, and distribution of a wide spectrum of healthcare treatments. With a global workforce of 25,000 individuals, the group is committed to its mission of pioneering quality healthcare solutions that have a positive impact on people’s lives. The group’s vision is to revolutionize lives through groundbreaking innovations in life sciences.
Zydus Lifesciences Limited, including its subsidiaries and affiliates, has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for ZITUVIMETTM (Sitagliptin and Metformin hydrochloride) tablets in both 50 mg/500 mg and 50 mg/1000 mg formulations.
ZITUVIMETTM combines the active ingredients sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide. It is indicated as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus.
The FDA approval for ZITUVIMETTM is the result of extensive research, development, regulatory compliance, and manufacturing efforts by Zydus. The product has been rigorously tested for Nitrosamines and potential genotoxic impurities in accordance with current USFDA standards, ensuring compliance in this regard.
Dr Sharvil Patel, Managing Director of Zydus Lifesciences Limited, highlighted that the approval of ZITUVIMETTM complements their previous approval of ZITUVIOTM (Sitagliptin), making prescription drugs for type II diabetes more accessible and affordable to healthcare systems. This approval provides an economical treatment option that can help healthcare systems reduce the growth rate of drug spending and enhance the financial sustainability of healthcare programs.
According to IQVIA data (MAT Aug-2023), the U.S. market for DPP-IV inhibitors and their combinations amounts to USD 10 billion.
The company has delivered returns of 31% over the past year and returns of 36% over the past 3 years. Additionally, the company has a ROCE of 15% and a ROE of 13.7%. Furthermore, the company has been able to grow its sales by 7% (CAGR) and net profit has grown by 17% (CAGR) for the same period.
On Monday, shares of the company surged over 1% and made an intraday high of Rs 591.05.
Investors should keep a close eye on this trending stock.
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