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Caplin Point Laboratories’ arm gets USFDA’s final approval for Acetaminophen Injection
Dec-08-2025

Caplin Point Laboratories’ subsidiary -- Caplin Steriles has received 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.

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

Caplin Point Laboratories is the mid-sized company in India’s pharmaceutical sector to be engaged in the manufacture of APIs, finished formulations, research & development, clinical research, frontend generic presence in Latin America, brand marketing in Francophone Africa and an USFDA approved injectable facility.

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