Caplin Point Laboratories announced that its subsidiary, Caplin Steriles Limited, has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Acetaminophen Injection, 1000 mg/100 mL (10 mg/mL) Single-dose Infusion Bags. This product is a generic therapeutic equivalent to the Reference Listed Drug (RLD) from Mallinckrodt Pharmaceuticals Ireland Limited. The product had US sales of approximately $86 million for the 12-month period ending October 2025.
USFDA Approval for Key Injectable
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories, has secured final USFDA approval for its ANDA concerning Acetaminophen Injection. The approved formulation is for 1000 mg/100 mL (10 mg/mL) Single-dose Infusion Bags, marking a significant milestone for the company’s sterile product offerings.
Acetaminophen Injection Details
The approved Acetaminophen Injection is therapeutically equivalent to the Reference Listed Drug (RLD) from Mallinckrodt Pharmaceuticals Ireland Limited. This injection is used for managing mild to moderate pain in adults and pediatric patients (2 years and older), as well as managing moderate to severe pain with opioid analgesics in the same patient groups. It also serves to reduce fever in both adult and pediatric patients.
Market Opportunity
According to IQVIATM (IMS Health) data, the US market for Acetaminophen Injection reached approximately $86 million in sales for the 12-month period ending October 2025. This approval enables Caplin Steriles to tap into this market with a generic alternative.
Caplin Steriles’ ANDA Portfolio
Caplin Steriles Limited has an active ANDA program with 53 ANDAs filed in the USA, including those developed independently and with partners. To date, the company has received 43 approvals, showcasing its strength in sterile product development and regulatory compliance.
Future Product Pipeline
The company is focused on developing a portfolio of 40+ simple and complex Injectable and Ophthalmic products, with plans to file these products over the coming years. Additionally, Caplin Steriles has filed multiple products in non-US markets, including Australia, Canada, and Mexico, among others.
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