Caplin Point | ANVISA-Brazil issues Zero observations to arm Caplin Steriles' injectable and Ophthalmic manufacturing facility located in Gummidipoondi. ANVISA is the Brazil drug regulator and had inspected the facility between August 12-16, 2024.
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CNBC TV1809-12-2025, 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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