Caplin Steriles Limited (Caplin), a subsidiary company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Acetaminophen Injection, 1000 mg/100 mL (10 mg/mL) Single-dose Infusion Bags, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Mallinckrodt Pharmaceuticals Ireland Limited.

Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older; the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older; and the reduction of fever in adult and pediatric patients.

According to IQVIATM (IMS Health), Acetaminophen Injection had US sales of approximately $86 million for the 12-month period ending October 2025.