Caplin Point secures US FDA nod for injection used to treat severe infections

Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories, has secured final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Linezolid

Injection 600mg/300mL in single-dose infusion bags.

The product is a generic equivalent of Pfizer’s ZYVOX and is primarily used to treat serious bacterial infections, including pneumonia and skin infections, especially those resistant to other antibiotics.

Global healthcare and analytics company, IQVIA data indicates US sales of around $23 million for the 12 months ended October 2025.

Caplin Steriles has so far developed and filed 53 ANDAs in the United States, with 44 approvals, and continues to work on a pipeline of more than 40 injectable and ophthalmic products for future filings.

The company also has approvals across several non-US markets, including Australia, Canada, Mexico, Chile, the UAE and Saudi Arabia.

For Q2FY26, Caplin Point Laboratories reported an 18% year-on-year rise in net profit to ₹154.4 crore, driven by a 10.6% increase in revenue to ₹534 crore. EBITDA grew 15% to ₹189.2 crore, with operating margins improving to 35.4% from 34.1% a year earlier.

As of 2:15 PM, shares of Caplin Point Laboratories were trading at ₹1,909.70 on the NSE, down 0.93%.