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  1. Zydus Lifesciences shares in focus on receiving tentative USFDA approval for type 2 diabetes treatment drugs

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Zydus Lifesciences shares in focus on receiving tentative USFDA approval for type 2 diabetes treatment drugs

Abha Raverkar

2 min read | Updated on November 27, 2025, 17:59 IST

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SUMMARY

“Empagliflozin and Linagliptin Tablets (10 mg/5 mg and 25 mg/5 mg) in 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,” it said.

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Zydus Lifesciences shares

Zydus Lifesciences develops, manufactures, and markets a broad range of healthcare therapies. | Image: Zyduslife.com

Zydus Lifesciences share price: Shares of Zydus Lifesciences will be in focus on Friday, November 28, after receiving a tentative approval from the United States Food and Drug Administration (USFDA) for type 2 diabetes treatment drugs.
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In a regulatory filing dated November 26, the drugmaker stated that it will produce Empagliflozin and Linagliptin tablets, 10 mg/5 mg and 25 mg/5 mg, at its formulation manufacturing facility at SEZ, Ahmedabad.

“Empagliflozin and Linagliptin Tablets (10 mg/5 mg and 25 mg/5 mg) in 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,” it added.

The tablets had annual sales worth $215.8 million in the US, according to IQVIA MAT Sept-2025 data.

As of September 30, the group has received 428 approvals and filed 487 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04.

Zydus enters into a pact with RK Pharma

In a separate regulatory filing on November 26, the company said that it entered into an exclusive licensing and commercialisation agreement for a novel 505(b)(2) product of supportive oncology treatment for the USA market.

Under the 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.

Zydus receives final approval from USFDA for high blood pressure treatment medicine

On November 25, the pharmaceutical firm said that it received the final approval from the USFDA for Verapamil Hydrochloride Extended-Release Tablets USP, 120 mg, 180 mg and 240 mg, it said in a regulatory filing.

The tablets are “used to lower high blood pressure, which helps reduce the risk of serious heart problems like strokes and heart attacks,” it added.

The tablets will be produced at Zydus Lifesciences Ltd, Baddi, Himachal Pradesh.

Shares of the company closed 0.16% lower at ₹939 apiece on the National Stock Exchange (NSE) on Thursday.

Zydus Lifesciences has a total market capitalisation of ₹94,485.37 crore, as of November 27, 2025, according to data on the NSE.

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About The Author

Abha Raverkar
Abha Raverkar is a post-graduate in economics from Christ University, Bengaluru. She has a strong interest in the markets and loves to unravel the nitty-gritties of the latest happenings in the world of markets, business, and the economy.

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