Caplin Steriles Limited Obtains FDA Approval for Linezolid Injection to Treat Bacterial Infections
Overview of FDA Approval for Linezolid Injection
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories, recently achieved a significant milestone by securing final FDA approval for its Linezolid Injection 600mg/300mL in single-dose infusion bags. This product serves as a generic equivalent of Pfizer's ZYVOX, predominantly focusing on the treatment of serious bacterial infections, such as pneumonia and skin infections resistant to other antibiotics.
Market Insights and Company Performance
According to global healthcare analytics from IQVIA, the US sales for this medication are projected at around $23 million for the 12 months ending October 2025. Caplin Steriles has developed and filed a total of 53 Abbreviated New Drug Applications (ANDAs) in the United States, with 44 receiving approvals. The company is actively expanding its pipeline, working on over 40 injectable and ophthalmic products for upcoming filings.
Financial Overview
In Q2 FY26, Caplin Point Laboratories reported a remarkable 18% year-on-year increase in net profit, reaching ₹154.4 crore. Revenue also saw a 10.6% rise to ₹534 crore, with EBITDA rising by 15% to ₹189.2 crore. Operating margins improved from 34.1% to 35.4% over the previous year.
- Shares of Caplin Point Laboratories were trading at ₹1,909.70 on the NSE, down 0.93%.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.