Zydus LifeSciences Gets USFDA Approval for Ibuprofen and Famotidine Tablets

Zydus Lifesciences Limited, formerly Cadila Healthcare Limited, is a leading Indian multinational pharmaceutical company headquartered in Ahmedabad, Gujarat. Founded in 1952 by Ramanbhai Patel and Indravadan Modi, it has grown into a global life sciences powerhouse with a presence in over 50 countries.

Approval from USFDA

In a significant regulatory milestone, Zydus Lifesciences has secured final approval from the United States Food and Drug Administration (USFDA) to manufacture Ibuprofen and Famotidine tablets (800 mg/26.6 mg). 

This novel combination therapy is indicated for the effective relief of symptoms associated with rheumatoid arthritis and osteoarthritis while concurrently mitigating the risk of upper gastrointestinal ulcers (gastric and/or duodenal) in patients undergoing ibuprofen treatment for these conditions. The production of these tablets will take place at the company’s state-of-the-art facility in the Special Economic Zone (SEZ), Ahmedabad.

The Ibuprofen and Famotidine tablets garnered annual sales of USD 3.6 million in the United States (IQVIA MAT December 2024). With this latest approval, Zydus Lifesciences now boasts an impressive portfolio of 415 approvals, having filed 483 Abbreviated New Drug Applications (ANDAs) since the inception of the filing process in FY 2003-04.

Zydus Lifesciences Q3 FY25 Results

The company delivered a stellar financial performance in Q3 FY25, with revenue soaring 17% year-on-year to ₹5,269.1 crore and net profit surging 30% to ₹1,023.5 crore. EBITDA witnessed a robust 26% growth, reaching ₹1,387.6 crore, with an enviable margin of 26.3%. Investments in research and development remained substantial at ₹503.1 crore (9.5% of revenue), while capital expenditure stood at ₹290.7 crore.

Segment-wise, the India formulations business recorded a steady 5% growth, generating ₹1,498.2 crore, whereas the U.S. formulations segment experienced a remarkable 30.8% surge to ₹2,409.6 crore. The consumer wellness division also posted a commendable 13% increase in revenue, amounting to ₹448.8 crore.

Share Price Performance 

At 10:18 AM on February 24, 2025, Zydus Lifesciences Ltd shares traded 1.36% higher at ₹897.36 per share on the NSE.

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