Zydus Lifesciences Share Price in Focus; Gets Tentative USFDA Nod for Type 2 Diabetes Treatment Tablets

Zydus Lifesciences has received a tentative approval from the US Food and Drug Administration for its Empagliflozin and Linagliptin tablets, available in 10 mg/5 mg and 25 mg/5 mg strengths.  

The combination is used alongside diet and exercise to help manage glycaemic levels in adults with type 2 diabetes who require both medications. The tablets will be produced at the company’s formulation plant located in the SEZ area of Ahmedabad. 

Ongoing Regulatory Activity 

The company has continued to expand its US regulatory portfolio over the years. Since FY 2003-04, Zydus has filed 487 ANDAs and obtained 428 approvals.  

In a separate development this week, it also received final approval from the USFDA for Verapamil Hydrochloride Extended-Release Tablets USP in 120 mg, 180 mg and 240 mg doses. 

New Licensing Arrangement 

Zydus recently signed an exclusive licensing and commercialisation agreement with RK Pharma Inc for a sterile injectable 505(b)(2) oncology supportive care product intended for the US market.  

RK Pharma will manufacture and supply the final product, while Zydus will take charge of the NDA submission and its commercial rollout once approved. 

Product Details 

The Empagliflozin-Linagliptin combination is meant for adults with type 2 diabetes who need both drugs as part of their treatment plan. It functions as an additional support to diet and exercise in routine diabetes management. 

Read More: Thyrocare Technologies Bonus Record Date on Nov 28: Declared 2:1 Bonus Issue! 

Zydus Lifesciences Share Price Performance  

As of November 28, 2025, 10:12 am, Zydus Lifesciences share price was trading at ₹937.60, a 0.037% increase from the previous closing price. 

Conclusion 

The tentative approval, combined with recent clearances and licensing activity, adds to the company’s ongoing US regulatory progress. The developments place another product in its pipeline for the US generics market. 

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