Caplin Steriles Limited, the sterile injectables subsidiary of Caplin Point Laboratories Limited, has secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Acetaminophen Injection, 1000 mg/100 mL (10 mg/mL) in single-dose infusion bags. The product is a generic and therapeutically equivalent version of the reference drug manufactured by Mallinckrodt Pharmaceuticals Ireland Limited.
This approval allows Caplin to enter the US market with an essential hospital-use analgesic and antipyretic widely administered for pain management and fever reduction. Acetaminophen Injection is prescribed for treating mild to moderate pain in adults and children above two years, and for managing moderate to severe pain when used together with opioid analgesics. It is also used for lowering fever across the same patient group, making it a critical supportive therapy in both surgical and emergency care settings.
The company noted that the approval strengthens its growing US injectable portfolio and reinforces its compliance track record with global regulatory authorities. Based on IQVIA (IMS Health) data, Acetaminophen Injection recorded US sales of nearly USD 86 million during the twelve-month period ending October 2025, underlining the market opportunity available for Caplin Steriles.
