The product is 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 IQVIA (IMS Health), Acetaminophen Injection had US sales of approximately $86 million for the 12-month period ending October 2025.
Caplin Steriles, a subsidiary of Caplin Point Laboratories Limited, is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles has developed and filed 53 ANDAs in USA on its own and with partners (including four ANDAs acquired from third parties), with 43 approvals so far. The Company is also working on a portfolio of 40 plus simple and complex Injectable and Ophthalmic products that it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, Saudi Arabia etc.
Its parent company, Caplin Point Laboratories Limited is a pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The Company has state of the art manufacturing facilities that cater to a complete range of finished dosage forms.
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