Caplin Point's Caplin Steriles wins US FDA nod for Linezolid Injection

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CNBC TV18•09-12-2025, 14:32
Caplin Point's Caplin Steriles wins US FDA nod for Linezolid Injection
- •Caplin Steriles, a Caplin Point subsidiary, received US FDA approval for Linezolid Injection 600mg/300mL.
- •The approved injection is a generic equivalent of Pfizer’s ZYVOX, used to treat severe bacterial infections like pneumonia and resistant skin infections.
- •The original product had US sales of approximately $23 million for the 12 months ending October 2025.
- •Caplin Steriles has secured 44 FDA approvals out of 53 Abbreviated New Drug Applications (ANDAs) filed.
- •Caplin Point Laboratories reported an 18% rise in net profit and a 10.6% increase in revenue for Q2FY26.
Why It Matters: It provides a new generic option for critical infection treatment.
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