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The inspection closed with seven observations. There were no data integrity related observations. The company will closely work with the USFDA to address the observations expeditiously.
The inspection concluded with seven observations. The company clarified that there were no data integrity-related observations.
Zydus Lifesciences said it will work closely with the USFDA to address the observations expeditiously.
Zydus Lifesciences is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
On a consolidated basis, Zydus Lifesciences' net profit rose 1.82% to Rs 1042.10 crore while net sales rose 32.34% to Rs 6780.40 crore in Q3 December 2025 over Q3 December 2024.
Zydus Lifesciences Ltd is up for a third straight session today. The stock is quoting at Rs 934.15, up 2.4% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.06% on the day, quoting at 24018.3. The Sensex is at 76839.15, down 0.23%. Zydus Lifesciences Ltd has gained around 6.94% in last one month.
Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has gained around 10.1% in last one month and is currently quoting at 23568.95, up 2.16% on the day. The volume in the stock stood at 6.71 lakh shares today, compared to the daily average of 7.09 lakh shares in last one month.
The benchmark May futures contract for the stock is quoting at Rs 936.9, up 1.98% on the day. Zydus Lifesciences Ltd is up 5.42% in last one year as compared to a 1.62% slide in NIFTY and a 12.19% slide in the Nifty Pharma index.
The PE of the stock is 19.53 based on TTM earnings ending December 25.
Zydus Lifesciences Ltd gained for a fifth straight session today. The stock is quoting at Rs 907, up 1.73% on the day as on 12:39 IST on the NSE. The benchmark NIFTY is down around 0.59% on the day, quoting at 23855.35. The Sensex is at 76913.19, down 0.84%. Zydus Lifesciences Ltd has slipped around 1.74% in last one month.
Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has slipped around 4.54% in last one month and is currently quoting at 21991.2, up 0.94% on the day. The volume in the stock stood at 3.71 lakh shares today, compared to the daily average of 6.62 lakh shares in last one month.
The benchmark April futures contract for the stock is quoting at Rs 908, up 1.63% on the day. Zydus Lifesciences Ltd is up 4.39% in last one year as compared to a 4.5% spurt in NIFTY and a 8.48% spurt in the Nifty Pharma index.
The PE of the stock is 19.1 based on TTM earnings ending December 25.
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg (USRLD: Farxiga® Tablets, 5 mg and 10 mg).
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Dapagliflozin Tablets, 5 mg and 10 mg.
Dapagliflozin tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad.
Dapagliflozin tablets had annual sales of USD 10.2bn in the United States (IQVIA MAT February 2026).
According to IQVIA MAT February 2026 data, Dapagliflozin tablets had annual sales of $10.2 billion in the United States. With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity. The group now has 436 USFDA approvals and has filed 505 ANDAs since it began filing in FY2003-04.
Zydus Lifesciences operates as an integrated pharmaceutical company across research, development, production, marketing, and distribution of pharmaceutical products.
The company’s consolidated net profit rose 7.7% to Rs 1,102.64 crore on a 32.3% increase in revenue from operations to Rs 6,780.40 crore in Q3 FY26 over Q3 FY25.