Caplin Point Laboratories subsidiary secures USFDA nod for acetaminophen infusion bags

Pharma company Caplin Point Laboratories Ltd

on Monday (December 8) informed that its subsidiary, Caplin Steriles Ltd, has received 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) single-dose infusion bags.

The product is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Mallinckrodt Pharmaceuticals Ireland Ltd. Acetaminophen injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older.

It is also indicated for the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older. The drug is also used for the reduction of fever in adult and pediatric patients.

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

Shares of Caplin Point Laboratories Ltd ended at ₹1,961.00, down by ₹2.05, or 0.10%, on the BSE.