Zydus Lifesciences Ltd Share Price – NSE  / BSE

Pharmaceuticals, Mid Cap

Zydus Lifesciences has received the Establishment Inspection Report (EIR) from the USFDA for a GMP follow-up inspection conducted at its injectable facility located at Jarod, Vadodara from 25 August to 05 September 2025 and classifying the facility as Voluntary Action Indicated (VAI). This inspection was conducted following the Warning Letter issued on 29 August 2024 by the USFDA.

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The approved ANDA is a generic version of the US reference listed drug Glyxambi Tablets.

Empagliflozin and Linagliptin Tablets, in a combination, are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

Empagliflozin and Linagliptin Tablets will be produced at the group?s formulation manufacturing facility at SEZ, Ahmedabad.

Empagliflozin and Linagliptin Tablets had annual sales of USD 215.8 mn in the United States (IQVIA MAT Sept-2025).

The group now has 428 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.

The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives.

Zydus Lifesciences reported a 38.12% jump in consolidated net profit to Rs 1,258.60 crore in Q2 FY26, compared with Rs 911.2 crore posted in Q2 FY25. Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26.

The scrip rose 0.54% to currently trade at Rs 942.35 on the BSE.

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Under the terms of the agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization in the US. The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and is designed to reduce dosing errors and enhance compliance among healthcare professionals.

The novel product targets a significant commercial opportunity in the US market, with an estimated total addressable market (TAM) of 6.2 million units, according to IQVIA MAT September 2025 data.

Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, said, ?We are delighted to collaborate with RK Pharma to bring this innovative product to patients in the US. This partnership reinforces our commitment to delivering high-quality, affordable medicines and improving patient care.?

Dr. Ravishanker Kovi, Founder and Executive Chairman of RK Pharma, stated, ?This novel 505(b)(2) product of supportive oncology treatment highlights RK Pharma?s testament to advanced capabilities in formulation and manufacturing, particularly in specialized areas like sterile injectables and complex generics. Our collaboration with Zydus, a company with robust regulatory expertise and a powerful commercial footprint, ensures that this important therapeutic option reaches patients efficiently, reinforcing our shared mission to improve access to high-quality healthcare in the USA.?

The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives.

Zydus Lifesciences reported a 38.12% jump in consolidated net profit to Rs 1,258.60 crore in Q2 FY26, compared with Rs 911.2 crore posted in Q2 FY25. Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26.

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Zydus Lifesciences has entered into an exclusive licensing and commercialization agreement with RK Pharma Inc of the US for a novel sterile injectable 505(b)(2) oncology supportive care product for the US market.

Under the terms of this agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US.

The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and will provide a formulation that is intended to provide reduced dosing error and enhanced compliance of healthcare professionals.

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