Zydus Lifesciences gets USFDA’s final approval for Ibuprofen and Famotidine Tablets

22 Feb 2025 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Ibuprofen and Famotidine tablets, 800 mg/26.6 mg. (USRLD: Duexis Tablets, 800 mg/26.6 mg).

Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers (gastric and/or duodenal ulcers), in patients who are taking ibuprofen for those indications. Ibuprofen and famotidine tablets will be produced at Zydus Lifesciences (SEZ), Ahmedabad.

Ibuprofen and Famotidine tablets had annual sales of $3.6 million in the United States (IQVIA MAT December 2024). The group now has 415 approvals and has so far filed 483 ANDAs since the commencement of the filing process in FY 2003-04. 

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.


Zydus Lifesciences Share Price

923.70 3.80 (0.41%)
10-Dec-2025 16:59 View Price Chart
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