Zydus Lifesciences has received final approval for its New Drug Application (NDA) from the United States Food and Drug Administration (USFDA) to market Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets. With this, the company has all three NDAs of Sitagliptin (base) and combination franchise approved through the 505(b) (2) route. Notably, all the three NDAs achieved First-Cycle Approval (FCA).
Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The product will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India. According to IQVIA (MAT May 2024), U.S. market for DPP-IV inhibitors and its combinations is $9.5 billion.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
| Company Name | CMP |
|---|---|
| Sun Pharma. Inds. | 1924.05 |
| Dr. Reddys Labs. | 1234.60 |
| Cipla | 1426.80 |
| Zydus Lifesciences | 1131.05 |
| Lupin | 2497.75 |
| View more.. | |
Start Research-backed Investing ...Now. Subscribe to Sapphire
MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.
To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.
MoneyWorks4Me ensures this through: